FDA Listing of Authorized Generics as of March 28, 2018
Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of data reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected]
A B C D E F G H I J K L M N O P Q R S T U V X Y Z
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 1 ACCOLATE Tablets 10 mg AstraZeneca
Pharmaceuticals 11/19/2010 Unknown
2 ACCOLATE Tablets 20 mg AstraZeneca Pharmaceuticals
11/19/2010 Unknown
3 ACCUPRIL Tablets 20 mg Pfizer Pharmaceuticals Ltd.
03/11/2004 Unknown
4 ACCUPRIL Tablets 40 mg Pfizer Pharmaceuticals Ltd.
03/11/2004 Unknown
5 ACCURETIC Tablets 10 mg/12.5 mg Pfizer 02/06/2006 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Pharmaceuticals Ltd.
6 ACCURETIC Tablets 20 mg/25 mg Pfizer Pharmaceuticals Ltd.
02/06/2006 Unknown
7 ACCURETIC Tablets 20 mg/12.5 mg Pfizer Pharmaceuticals Ltd.
02/06/2006 Unknown
8 ACEPHEN Suppositories 120 mg G & W Laboratories, Inc.
Prior to 1/1/1999 Unknown
9 ACETADOTE Injection 6g/30mL (200 mg/mL) Cumberland Pharmaceuticals, Inc.
1/7/2013 Unknown
10 ACTIGALL Capsules 300 mg Allergan Sales, LLC 08/13/2003 Unknown 11 ACTIQ Lozenge 400 mcg Cephalon, Inc. 09/26/2006 Unknown 12 ACTIQ Lozenge 600 mcg Cephalon, Inc. 09/26/2006 Unknown 13 ACTIQ Lozenge 800 mcg Cephalon, Inc. 09/26/2006 Unknown 14 ACTIQ Lozenge 1200 mcg Cephalon, Inc. 09/26/2006 Unknown 15 ACTIQ Lozenge 1600 mcg Cephalon, Inc. 09/26/2006 Unknown 16 ACTIQ Lozenge 200 mcg Cephalon, Inc. 09/26/2006 Unknown 17 ACTIVELLA Tablets 1 mg / 0.5 mg Amneal
Pharmaceuticals 2014 - 2015 Unknown
18 ACTIVELLA Tablets 0.5 mg / 0.1 mg Amneal Pharmaceuticals
2014 - 2015 Unknown
19 ACTONEL Tablets 150 mg Warner Chilcott Company LLC
06/2014 Unknown
20 ACTOPLUS-MET Tablets 15 mg/850 mg Takeda Pharmaceuticals USA
08/2013 - 07/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 21 ACTOPLUS-MET Tablets 15 mg/500 mg Takeda
Pharmaceuticals USA Unknown Unknown
22 ACTOS Tablets 30 mg Takeda Pharmaceuticals USA
08/17/2012 Unknown
23 ACTOS Tablets 15 mg Takeda Pharmaceuticals USA
08/17/2012 Unknown
24 ACTOS Tablets 45 mg Takeda Pharmaceuticals USA
08/17/2012 Unknown
25 ACULAR LS Ophthalmic Solution
0.4% Allergan, Inc. 11/11/2013 Unknown
26 ADALAT CC Extended-release Tablets
30 mg Alvogen Group Holdings LLC
04/21/1993 Unknown
27 ADALAT CC Extended-release Tablets
60 mg Alvogen Group Holdings LLC
04/21/1993 Unknown
28 ADALAT CC Extended-release Tablets
90 mg Alvogen Group Holdings LLC
04/21/1993 Unknown
29 ADDERALL XR Extended-release Capsules
5 mg Shire Development, LLC
12/17/2013 Unknown
30 ADDERALL XR Extended-release Capsules
30 mg Shire Development, LLC
09/30/2009 Unknown
31 ADDERALL XR Extended-release Capsules
20 mg Shire Development LLC
04/02/2009 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 32 ADDERALL XR Extended-
release Capsules
10 mg Shire Development, LLC
10/2016 - 10/2017 Unknown
33 ADDERALL XR Extended-release Capsules
15 mg Shire Development, LLC
10/2016 - 10/2017 Unknown
34 ADDERALL XR Extended-release Capsules
20 mg Shire Development, LLC
10/2016 - 10/2017 Unknown
35 ADDERALL XR Extended-release Capsules
25 mg Shire Development, LLC
10/2016 - 10/2017 Unknown
36 ADDERALL XR Extended-release Capsules
30 mg Shire Development, LLC
10/2016 - 10/2017 Unknown
37 ADDERALL XR Extended-release Capsules
30 mg Shire Development LLC
04/02/2009 Unknown
38 ADDERALL XR Extended-release Capsules
25 mg Shire Development LLC
04/02/2009 Unknown
39 ADDERALL XR Extended-release Capsules
25 mg Shire Development, LLC
09/30/2009 Unknown
40 ADDERALL XR Extended- 10 mg Shire Development, 09/30/2009 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing release Capsules
LLC
41 ADDERALL XR Extended-release Capsules
20 mg Shire Development, LLC
09/30/2009 Unknown
42 ADDERALL XR Extended-release Capsules
5 mg Shire Development LLC
10/2016 - 10/2017 Unknown
43 ADDERALL XR Extended-release Capsules
15 mg Shire Development, LLC
09/30/2009 Unknown
44 ADDERALL XR Extended-release Capsules
15 mg Shire Development LLC
04/02/2009 Unknown
45 ADDERALL XR Extended-release Capsules
5 mg Shire Development LLC
04/02/2009 Unknown
46 ADDERALL XR Extended-release Capsules
10 mg Shire Development LLC
04/02/2009 Unknown
47 ADDERALL XR Extended-release Capsules
5 mg Shire Development, LLC
04/02/2009 Unknown
48 ADDERALL XR Extended-release
10 mg Shire Development, LLC
04/02/2009 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Capsules
49 ADDERALL XR Extended-release Capsules
15 mg Shire Development, LLC
04/02/2009 Unknown
50 ADDERALL XR Extended-release Capsules
20 mg Shire Development, LLC
04/02/2009 Unknown
51 ADDERALL XR Extended-release Capsules
25 mg Shire Development, LLC
04/02/2009 Unknown
52 ADDERALL XR Extended-release Capsules
30 mg Shire Development, LLC
04/02/2009 Unknown
53 ADRENACLICK Injection 0.15 mg Amedra 04/01/2010 Unknown 54 ADRENACLICK Injection 0.3 mg Amedra 04/01/2010 Unknown 55 ALDACTAZIDE Tablets 25 mg/25 mg G.D. Searle LLC 10/06/2003 Unknown 56 ALDACTONE Tablets 25 mg G.D. Searle LLC 6/18/2003 Unknown 57 ALDACTONE Tablets 50 mg G.D. Searle LLC 6/18/2003 Unknown 58 ALDACTONE Tablets 100 mg G.D. Searle LLC 6/18/2003 Unknown 59 ALLEGRA Tablets 30 mg Sanofi Aventis US
LLC 02/2005 - 02/2006 Unknown
60 ALLEGRA Tablets 60 mg Sanofi Aventis US LLC
02/2005 - 02/2006 Unknown
61 ALLEGRA Tablets 180 mg Sanofi Aventis US 02/2005 - 02/2006 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing LLC
62 ALLEGRA-D 12 HOUR
Extended-release Tablets
60 mg/120 mg Sanofi Aventis US LLC
12/2004 - 12/2005 Unknown
63 AMARYL Tablets 1 mg Sanofi Aventis US LLC
11/2004 - 11/2005 Unknown
64 AMARYL Tablets 2 mg Sanofi Aventis US LLC
11/2004 - 11/2005 Unknown
65 AMARYL Tablets 4 mg Sanofi Aventis US LLC
11/2004 - 11/2005 Unknown
66 AMBIEN Tablets 5 mg Sanofi Aventis US LLC
12/2006 - 12/2007 Unknown
67 AMBIEN Tablets 10 mg Sanofi Aventis US LLC
12/2006 - 12/2007 Unknown
68 AMBIEN CR Extended-release Tablets
6.25 mg Sanofi Aventis U.S. LLC
10/2010 Unknown
69 AMBIEN CR Extended-release Tablets
12.5 mg Sanofi Aventis U.S. LLC
12/2010 Unknown
70 AMICAR Tablets 1000 mg Clover Pharmaceuticals Corporation
06/01/2012 Unknown
71 AMOXIL Powder for Oral Suspension
200 mg/5 mL when reconstituted
Dr. Reddy's Laboratories Inc.
04/15/1999 Unknown
72 AMOXIL Powder for Oral
400 mg/5 mL when reconstituted
Dr. Reddy's Laboratories Inc.
04/15/1999 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Suspension
73 AMOXIL Tablets 500 mg Dr. Reddy's Laboratories Inc.
07/10/1978 Unknown
74 AMOXIL Tablets 875 mg Dr. Reddy's Laboratories Inc.
07/10/1978 Unknown
75 ANAFRANIL Capsules 75 mg Mallinckrodt 07/2015 Unknown 76 ANAFRANIL Capsules 50 mg Mallinckrodt 07/2015 Unknown 77 ANAFRANIL Capsules 25 mg Mallinckrodt 07/2015 Unknown 78 ANCOBAN Capsules 250 mg Valeant
Pharmaceuticals North America LLC
07/2017 Unknown
79 ANCOBAN Capsules 500 mg Valeant Pharmaceuticals North America LLC
01/17/2012 Unknown
80 ANGIOMAX Injection 250 mg The Medicines Company
10/2015 Unknown
81 ANTARA Capsules 43 mg Lupin Atlantis Holdings, S.A.
02/22/2013 Unknown
82 ANTARA Capsules 130 mg Lupin Atlantis Holdings, S.A.
02/22/2013 Unknown
83 ARAVA Tablets 20 mg Sanofi Aventis US LLC
09/07/2015 Unknown
84 ARAVA Tablets 10 mg Sanofi Aventis US LLC
09/07/2015 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 85 ARICEPT Film coated
tablets 5 mg Eisai, Inc. 11/25/2009 - 11/24/2010 Unknown
86 ARICEPT Film coated tablets
10 mg Eisai, Inc. 11/25/2009 - 11/24/2010 Unknown
87 ARICEPT ODT Orally disintegrating tablets
10 mg Eisai, Inc. 10/18/2009 - 11/24/2010 Unknown
88 ARICEPT ODT Orally distinegrating tablets
5 mg Eisai, Inc. 10/18/2009 - 11/24/2010 Unknown
89 ARIXTRA Injection 7.5 mg / 0.6 mL Mylan Ireland Limited
12/2014 - 12/2015 Unknown
90 ARIXTRA Injection 5 mg / 0.4 mL Mylan Ireland Limited
12/2014 - 12/2015 Unknown
91 ARIXTRA Injection 10 mg / 0.8 mL Mylan Ireland Limited
12/2014 - 12/2015 Unknown
92 ARIXTRA Injection 2.5 mg / 0.5 mL Mylan Ireland Limited
12/2014 - 12/2015 Unknown
93 AROMASIN Tablets 25 mg Pharmacia & Upjohn 11/02/2010 Unknown 94 ARTHROTEC Tablets 50 mg/200 mcg GD Searle LLC 07/10/2011 Unknown 95 ARTHROTEC Tablets 75 mg/200 mcg GD Searle LLC 07/10/2011 Unknown 96 ASTELIN Nasal Spray 137 mcg Meda
Pharmaceuticals, Inc. 8/31/2010 Unknown
97 ATACAND Tablets 8 mg AstraZeneca 05/21/2013 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Pharmaceuticals
98 ATACAND Tablets 16 mg AstraZeneca Pharmaceuticals
05/21/2013 Unknown
99 ATACAND Tablets 32 mg AstraZeneca Pharmaceuticals
05/21/2013 Unknown
100 ATACAND Tablets 4 mg AstraZeneca Pharmaceuticals
05/21/2013 Unknown
101 ATIVAN Injection 2 mg/mL Baxter Healthcare Corporation
10/31/2003 Unknown
102 ATIVAN Injection 4 mg/mL Baxter Healthcare Corporation
10/31/2003 Unknown
103 ATRALIN Gel 0.05% Dow Pharmaceutical Sciences, a Divison of VPNA
07/26/2007 Unknown
104 ATRALIN Gel 0.05% Dow Pharmaceutical Sciences, a Division of VPNA
06/19/2014 Unknown
105 AUGMENTIN Oral Suspension
250 mg/62.5 mg per 5 mL Dr. Reddy's Laboratories Inc.
10/1990 Unknown
106 AUGMENTIN Oral Suspension
200 mg/28.5 mg per 5 mL Dr. Reddy's Laboratories Inc.
10/22/1990 Unknown
107 AUGMENTIN Oral Suspension
400 mg/57 mg per 5 mL Dr. Reddy's Laboratories Inc.
10/22/1990 Unknown
108 AUGMENTIN Tablets 250 mg Dr. Reddy's Laboratories Inc.
10/22/1990 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 109 AUGMENTIN Tablets 500 mg Dr. Reddy's
Laboratories Inc. 10/22/1990 Unknown
110 AUGMENTIN Tablets 875 mg Dr. Reddy's Laboratories Inc.
10/02/1996 Unknown
111 AUGMENTIN ES-600 Powder for Oral Suspension
600 mg/42.9 mg per 5 mL Dr. Reddy's Laboratories Inc.
06/22/2001 Unknown
112 AVALIDE Tablets 300 mg/12.5 mg Sanofi-Aventis LLC 09/01/2011 - 08/31/2012 Unknown 113 AVALIDE Tablets 150 mg/12.5 mg Sanofi-Aventis LLC 09/01/2011 - 08/31/2012 Unknown 114 AVAPRO Tablets 150 mg Sanofi-Aventis LLC 09/01/2011 - 08/31/2012 Unknown 115 AVAPRO Tablets 75 mg Sanofi-Aventis LLC 09/01/2011 - 08/31/2012 Unknown 116 AVAPRO Tablets 300 mg Sanofi-Aventis LLC 09/01/2011 - 08/31/2012 Unknown 117 AVELOX Tablets 400 mg Bayer HealthCare
Pharmaceuticals Unknown Unknown
118 AVITA Cream 0.025% Mylan Pharmaceuticals, Inc.
05/01/1998 Unknown
119 AXERT Tablets 12.5 mg Janssen Research & Development, LLC
07/2015 Unknown
120 AXERT Tablets 6.25 mg Janssen Research & Development, LLC
07/2015 Unknown
121 AZILECT Tablets 0.5 mg Teva Neuroscience, Inc.
01/2017 Unknown
122 AZILECT Tablets 1 mg Teva Neuroscience, Inc.
01/2017 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 123 AZOR Tablets 10 mg/ 20 mg Daiichi Sankyo Inc. 10/2016 Unknown 124 AZOR Tablets 5 mg/ 40 mg Daiichi Sankyo Inc. 10/2016 Unknown 125 AZOR Tablets 10 mg/ 40 mg Daiichi Sankyo Inc. 10/2016 Unknown 126 AZOR Tablets 5 mg/20 mg Daiichi Sankyo Inc. 10/2016 Unknown 127 AZULFIDINE Tablets 500 mg Pharmacia and
Upjohn Company 07/14/2003 Unknown
128 AZULFIDINE EN-TABS
Delayed-release Tablets
500 mg Pharmacia and Upjohn Company
06/17/2003 Unknown
129 BENICAR Tablets 5 mg Daiichi Sankyo, Inc 10/2016 Unknown 130 BENICAR Tablets 40 mg Daiichi Sankyo, Inc 10/2016 Unknown 131 BENICAR Tablets 20 mg Daiichi Sankyo, Inc 10/2016 Unknown 132 BENICAR HCT Tablets 40 mg/12.5 mg Daiichi Sankyo, Inc 10/2016 Unknown 133 BENICAR HCT Tablets 40 mg/25 mg Daiichi Sankyo, Inc 10/2016 Unknown 134 BENICAR HCT Tablets 20 mg/12.5 mg Daiichi Sankyo, Inc 10/2016 Unknown 135 BENZACLIN Topical Gel 1% / 5% Valeant
Pharmaceuticals North Americal LLC
05/2017 Unknown
136 BENZAMYCIN Topical Gel 3% Erythromycin, 5% Benzoyl Peroxide
Valeant Pharmaceuticals North America LLC
10/2014 - 10/2015 Unknown
137 BENZAMYCIN Topical Gel 3% Erythromycin, 5% Benzoyl Peroxide
Valeant Pharmaceuticals North America LLC
10/26/1984, 05/07/2013 Unknown
138 BETAGAN Ophthalmic 0.5% Allergan, Inc. 07/15/1997 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Solution
139 BETAGAN Ophthalmic Solution
0.25% Allergan, Inc. 07/15/1997 Unknown
140 BETOPTIC Ophthalmic Solution
eq. 0.5% base Alcon Laboratories, Inc.
05/08/2000 Unknown
141 BIAXIN Granules for Oral Suspension
250 mg per 5 mL when reconstituted (100 mL bottle)
AbbVie Inc. 05/2012 Unknown
142 BIAXIN Granules for Oral Suspension
125 mg per 5 mL when reconstituted (50 mL bottle)
AbbVie Inc. 05/2012 Unknown
143 BLOCADREN Tablets 5 mg Merck & Co., Inc. Prior to 1/1/1999 Unknown 144 BLOCADREN Tablets 10 mg Merck & Co., Inc. Prior to 1/1/1999 Unknown 145 BREVIBLOC Injection 10 mg/mL Baxter Healthcare
Corporation 11/2002 - 10/2003 Unknown
146 BROMDAY Ophthalmic Solution
0.09% Bausch & Lomb Inc. 10/16/2013 Unknown
147 BUMEX Tablets 0.5 mg Validus Pharmaceuticals LLC
10/2015 Unknown
148 BUMEX Tablets 1 mg Validus Pharmaceuticals LLC
10/2015 Unknown
149 BUMEX Tablets 2 mg Validus Pharmaceuticals LLC
10/2015 Unknown
150 BUTRANS Transdermal 15 mcg/hour Purdue Pharma L.P. 05/2017 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing System
151 BUTRANS Transdermal System
20 mcg/hour Purdue Pharma L.P. 05/2017 Unknown
152 BUTRANS Transdermal System
5 mcg/hour Purdue Pharma L.P. 05/2017 Unknown
153 BUTRANS Transdermal System
10 mcg/hour Purdue Pharma L.P. 05/2017 Unknown
154 CADUET Tablet 5 mg/80 mg PF Prism C.V. 11/3/2011 Unknown 155 CADUET Tablet 2.5 mg/20 mg PF Prism C.V. 11/3/2011 Unknown 156 CADUET Tablet 2.5 mg/10 mg PF Prism C.V. 04/04/2014 Unknown 157 CADUET Tablet 5 mg/10 mg PF Prism C.V. 04/04/2014 Unknown 158 CADUET Tablet 5 mg/40 mg PF Prism C.V. 04/04/2014 Unknown 159 CADUET Tablet 10 mg/40 mg PF Prism C.V. 11/3/2011 Unknown 160 CADUET Tablet 2.5 mg/10 mg PF Prism C.V. 11/3/2011 Unknown 161 CADUET Tablet 2.5 mg/20 mg PF Prism C.V. 04/04/2014 Unknown 162 CADUET Tablet 10 mg/10 mg PF Prism C.V. 11/3/2011 Unknown 163 CADUET Tablet 5 mg/20 mg PF Prism C.V. 11/3/2011 Unknown 164 CADUET Tablet 2.5 mg/40 mg PF Prism C.V. 11/3/2011 Unknown 165 CADUET Tablet 2.5 mg/40 mg PF Prism C.V. 04/04/2014 Unknown 166 CADUET Tablet 5 mg/10 mg PF Prism C.V. 11/3/2011 Unknown 167 CADUET Tablet 10 mg/20 mg PF Prism C.V. 11/3/2011 Unknown 168 CADUET Tablet 5 mg/20 mg PF Prism C.V. 04/04/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 169 CADUET Tablet 10 mg/80 mg PF Prism C.V. 11/10/2011 Unknown 170 CADUET Tablet 5 mg/80 mg PF Prism C.V. 04/04/2014 Unknown 171 CADUET Tablet 10 mg/10 mg PF Prism C.V. 04/04/2014 Unknown 172 CADUET Tablet 5 mg/40 mg PF Prism C.V. 11/3/2011 Unknown 173 CADUET Tablet 10 mg/80 mg PF Prism C.V. 04/04/2014 Unknown 174 CADUET Tablet 10 mg/40 mg PF Prism C.V. 04/04/2014 Unknown 175 CADUET Tablet 10 mg/20 mg PF Prism C.V. 04/04/2014 Unknown 176 CARAC Cream 0.5% Valeant
Pharmaceuticals North America LLC
10/28/2014 Unknown
177 CARAFATE Tablets 1 g Allergan Sales, LLC 11/01/1996 Unknown 178 CARBATROL Extended-
Release Capsules
100 mg Shire Development LLC
12/15/2011 Unknown
179 CARBATROL Extended-Release Capsules
200 mg Shire Development LLC
12/15/2011 Unknown
180 CARBATROL Extended-Release Capsules
300 mg Shire Development LLC
12/15/2011 Unknown
181 CARDIOLITE Injection (per label) Lantheus Medical Imaging, Inc.
12/1990 Unknown
182 CARDIZEM Tablets 30 mg Valeant Pharmaceuticals
Prior to 1/1/1999 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing North American LLC
183 CARDIZEM Tablets 60 mg Valeant Pharmaceuticals North American LLC
Prior to 1/1/1999 Unknown
184 CARDIZEM Tablets 90 mg Valeant Pharmaceuticals North American LLC
Prior to 1/1/1999 Unknown
185 CARDIZEM Tablets 120 mg Valeant Pharmaceuticals North American LLC
Prior to 1/1/1999 Unknown
186 CARDIZEM CD Capsules 360 mg Valeant Pharmaceuticals North America, LLC
08/09/2012 Unknown
187 CARDIZEM LA Tablets 420 mg Valeant Pharmaceuticals North America, LLC
02/06/2014 Unknown
188 CARDIZEM LA Tablets 180 mg Valeant Pharmaceuticals North America, LLC
02/06/2014 Unknown
189 CARDIZEM LA Tablets 240 mg Valeant Pharmaceuticals North America, LLC
02/06/2014 Unknown
190 CARDIZEM LA Tablets 360 mg Valeant Pharmaceuticals North America, LLC
02/06/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 191 CARDIZEM LA Tablets 300 mg Valeant
Pharmaceuticals North America, LLC
02/06/2014 Unknown
192 CARNITOR Oral Solution 1 gm/10 mL Sigma-Tau Pharmaceuticals, Inc.
04/2005 - 04/2006 Unknown
193 CARNITOR Tablets 330 mg Sigma-Tau Pharmaceuticals, Inc.
1/2005 - 12/2005 Unknown
194 CEDAX Capsules 400 mg Pernix Therapeutics LLC
10/22/2013 Unknown
195 CEDAX Powder, for Oral Suspension
60 mL when reconstituted (180 mg per 5 mL)
Pernix Therapeutics LLC
10/22/2013 Unknown
196 CELEBREX Capsules 200 mg G.D. Searle, LLC 12/10/2014 Unknown 197 CELEBREX Capsules 100 mg G.D. Searle, LLC 12/10/2014 Unknown 198 CELEBREX Capsules 100 mg G.D. Searle, LLC 12/10/2014 Unknown 199 CELEBREX Capsules 100 mg G.D. Searle, LLC 12/10/2014 Unknown 200 CELEBREX Capsules 200 mg G.D. Searle, LLC 12/10/2014 Unknown 201 CELEBREX Capsules 200 mg G.D. Searle, LLC 12/10/2014 Unknown 202 CELEBREX Capsules 400 mg G.D. Searle, LLC 12/10/2014 Unknown 203 CELEBREX Capsules 200 mg G.D. Searle, LLC 12/10/2014 Unknown 204 CELEBREX Capsules 50 mg G.D. Searle, LLC 12/10/2014 Unknown 205 CHILDREN'S
MOTRIN Suspension 100 mg/5 mL McNeil Consumer
Healthcare 06/1998 - 06/1999 Unknown
206 CHILDREN'S Suspension/ 40 mg/mL McNeil Consumer Prior to 1/1/1999 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing MOTRIN (aka INFANT'S MOTRIN)
Drops Healthcare
207 CILOXAN Ophthalmic Solution
0.3% Novartis Pharmaceuticals Corporation
05/28/2004 Unknown
208 CIPRO for Oral Suspension
250 mg/5 mL Bayer Pharmaceuticals Corp.
06/2003 Unknown
209 CIPRO for Oral Suspension
500 mg/5 mL Bayer Pharmaceuticals Corp.
06/2003 Unknown
210 CIPRO Tablets eq. 250 mg base Bayer Pharmaceuticals Corp.
Prior to 1/1/1999 Unknown
211 CIPRO Tablets eq. 500 mg base Bayer Pharmaceuticals Corp.
Prior to 1/1/2000 Unknown
212 CIPRO Tablets eq. 750 mg base Bayer Pharmaceuticals Corp.
Prior to 1/1/2001 Unknown
213 CLEOCIN Vaginal Cream
2% Pharmacia and Upjohn Company
12/17/2005 Unknown
214 CLEOCIN HCl Capsules 150 mg Pharmacia and Upjohn Company
07/11/2003 Unknown
215 CLEOCIN HCl Capsules 300 mg Pharmacia and Upjohn Company
06/18/2003 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 216 CLEOCIN
PEDIATRIC Flavored Granules for Oral Solution
75 mg/5 mL (100 mL when mixed)
Pharmacia and Upjohn Company
07/28/2010 Unknown
217 CLEOCIN T Topical Gel 1% Pharmacia and Upjohn Company
06/11/2003 Unknown
218 CLEOCIN T Topical Lotion 1% Pharmacia and Upjohn Company
06/18/2003 Unknown
219 CLEOCIN T Topical Solution
1% Pharmacia and Upjohn Company
06/11/2003 Unknown
220 CLINORIL Tablets 150 mg Merck & Co., Inc. Prior to 1/1/1999 Unknown 221 CLINORIL Tablets 200 mg Merck & Co., Inc. Prior to 1/1/1999 Unknown 222 CLOBEX Emulsion,
Lotion 0.05% Galderma
Laboratories, L.P. 01/03/2012 Unknown
223 CLOBEX Shampoo 0.05% Galderma Laboratories
12/2011 Unknown
224 CLOBEX Spray 0.05% Galderma Laboratories, L.P.
08/2015 Unknown
225 CLODERM Cream 0.1% Promius Pharma, LLC
02/17/2014 Unknown
226 CLOLAR Injection 20mg/20mL Genzyme Corporation
05/2017 Unknown
227 CLOMID Tablets 50 mg Hoechst Marion Roussel, Inc.
Prior to 1/1/1999 Unknown
228 CLOZARIL Tablets 25 mg Heritage Life Sciences 09/2017 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing (USA), Inc.
229 CLOZARIL Tablets 100 mg Heritage Life Sciences (USA), Inc.
09/2017 Unknown
230 COGENTIN Injection 2 mg/2 mL (2 mL ampule)
Oak Pharmaceuticals 08/08/2012 Unknown
231 COLAZAL Capsules 750 mg Salix Pharmaceuticals, Inc.
01/2008 Unknown
232 COLCRYS Tablets 0.6 mg Takeda Pharmaceuticals U.S.A. Inc.
01/09/2015 Unknown
233 COLESTID Granules for Oral Suspension
5 g per dose Pharmacia and Upjohn Company
01/11/2016 Unknown
234 COLESTID Tablets 1 g Pharmacia and Upjohn
02/2007 Unknown
235 COLY-MYCIN M for Injection 150 mg/vial (single dose vial)
Par Sterile Products, LLC
06/01/2012 Unknown
236 COLYTE for Oral Solution
240 gm/bot; 5.84 gm/bot; 2.98 gm/bot; 6.72 gm/bot; 22.72 gm/bot
Meda Pharmaceuticals Inc.
10/1996 Unknown
237 COMTAN Tablets 200 mg Orion Corporation 6/26/2013 Unknown 238 COMTAN Tablets 200 mg Orion Corporation 10/1/2012 Unknown 239 COMTAN Tablets 200 mg Orion Corporation 4/1/2013 Unknown 240 COMTAN Tablets 200 mg Orion Corporation 06/04/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 241 CONCERTA Extended-
release Tablets 18 mg Janssen Research and
Development, LLC 5/1/2011 Unknown
242 CONCERTA Extended-release Tablets
27 mg Janssen Research and Development, LLC
5/1/2011 Unknown
243 CONCERTA Extended-release Tablets
54 mg Janssen Research and Development, LLC
5/1/2011 Unknown
244 CONCERTA Extended-release Tablets
36 mg Janssen Research and Development, LLC
5/1/2011 Unknown
245 CONDYLOX Topical Solution
0.5% Allergan Sales, LLC 12/16/2003 Unknown
246 CONZIP Extended-release Capsules
200 mg Cipher Pharmaceuticals, Inc.
05/2015 Unknown
247 CONZIP Extended-release Capsules
300 mg Cipher Pharmaceuticals, Inc.
06/2015 Unknown
248 CONZIP Extended-release Capsules
100 mg Cipher Pharmaceuticals, Inc.
06/2015 Unknown
249 CONZIP Extended-release Capsules
150 mg Cipher Pharmaceuticals, Inc.
06/2012 Unknown
250 CORGARD Tablets 80 mg US WorldMeds, LLC 05/05/2014 Unknown 251 CORGARD Tablets 40 mg US WorldMeds, LLC 05/05/2014 Unknown 252 CORGARD Tablets 20 mg US WorldMeds, LLC 05/05/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 253 CORTEF Tablets 10 mg Pharmacia and
Upjohn Company LLC
12/21/2012 Unknown
254 CORTEF Tablets 5 mg Pharmacia and Upjohn Company LLC
12/21/2012 Unknown
255 CORTEF Tablets 20 mg Pharmacia and Upjohn Company LLC
12/22/2012 Unknown
256 CORTENEMA Rectal Suspension
100 mg/60 mL ANI Pharmaceuticals, Inc.
08/2012 Unknown
257 CORTISPORIN OTIC Otic Solution eq. 3.5 mg base/g; 10,000 units/g; 1%
Monarch Pharmaceuticals Inc.
1/11/1999 Unknown
258 COSMEGEN Powder, for injection solution, lyophilized
500 mcg (0.5 mg) Recordati Rare Diseases Inc.
12/2017 Unknown
259 COZAAR Tablet, Film Coated
25 mg Merck Sharp & Dohme Corp.
4/6/2010 Unknown
260 COZAAR Tablet, Film Coated
50 mg Merck Sharp & Dohme Corp.
4/6/2010 Unknown
261 COZAAR Tablet, Film Coated
100 mg Merck Sharp & Dohme Corp.
4/6/2010 Unknown
262 CUTIVATE Cream 0.05% GlaxoSmithKline Consumer
11/2003 - 11/2004 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Healthcare
263 CUTIVATE Lotion 0.05% Fougera Pharmaceuticals, Inc.
10/05/2009 Unknown
264 CUTIVATE Ointment 0.005% GlaxoSmithKline Consumer Healthcare
11/2003 - 11/2004 Unknown
265 CYCLESSA Tablets 0.1 mg, 0.125 mg, 0.15 mg; 0.025 mg, 0.025 mg, 0.025 mg
Organon USA Inc. 9/15/2004 Unknown
266 CYTOTEC Tablets 200 mcg GD Searle LLC 06/18/2003 Unknown 267 CYTOTEC Tablets 100 mcg GD Searle LLC 06/18/2003 Unknown 268 DANTRIUM Capsules 50 mg Par Sterile Products,
LLC 04/08/2013 Unknown
269 DANTRIUM Capsules 100 mg Par Sterile Products, LLC
02/2016 Unknown
270 DANTRIUM Capsules 25 mg Par Sterile Products, LLC
04/08/2013 Unknown
271 DAYPRO Tablets 600 mg GD Searle LLC 03/28/2013 Unknown 272 DDAVP Nasal Solution 0.1 mL (10 mcg) per
actuation Ferring Pharmaceuticals, Inc.
07/2016 Unknown
273 DDAVP Tablets 0.1 mg Ferring Pharmaceuticals, Inc.
12/2015 Unknown
274 DDAVP Tablets 0.2 mg Ferring Pharmaceuticals, Inc.
12/2015 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 275 DDAVP,
DESMOPRESSIN ACETATE
Injection 4 mcg/mL Ferring Pharmaceuticals Inc.
01/2016 Unknown
276 DELESTROGEN Injection 20 mg/mL Par Sterile Products 06/01/2012 Unknown 277 DELESTROGEN Injection 40 mg/mL Par Sterile Products 06/01/2012 Unknown 278 DELESTROGEN Injection 10 mg/mL Par Sterile Products 06/01/2012 Unknown 279 DEPAKOTE ER Extended-
release Tablets 250 mg Abbvie Inc. 08/2013 Unknown
280 DEPAKOTE ER Extended-release Tablets
500 mg Abbvie Inc. 08/2013 Unknown
281 DEPAKOTE SPRINKLE CAPSULES
Capsules 125 mg AbbVie Inc. 08/31/2015 Unknown
282 DEPO-MEDROL Injection 40 mg/mL Pharmacia and Upjohn
05/2006 - 05/2007 Unknown
283 DEPO-MEDROL Injection 80 mg/mL Pharmacia and Upjohn
05/2006 - 05/2007 Unknown
284 DEPO-PROVERA Injection 150 mg/mL Pharmacia and Upjohn
09/16/2004 Unknown
285 DERMA-SMOOTHE/FS
Oil 0.01% Hill Dermaceuticals Inc.
08/20/2013 Unknown
286 DERMATOP EMOLLIENT CREAM
Cream 0.1% Valeant Pharmaceuticals North America, LLC
10/2006 - 10/2007 Unknown
287 DERMOTIC Oil 0.01% Hill Dermaceuticals Unknown Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Inc.
288 DESMOPRESSIN ACETATE
Nasal Spray 10 mcg per 0.1 mL (5 mL bottle)
Ferring Pharmaceuticals, Inc.
11/20/2014 Unknown
289 DESOWEN Cream 0.05% Galderma Laboratories, L.P.
07/2013 Unknown
290 DETROL Tablets 1 mg Pharmacia and Upjohn
01/23/2014 Unknown
291 DETROL Tablets 2 mg Pharmacia and Upjohn
01/23/2014 Unknown
292 DETROL Tablets 1 mg Pharmacia and Upjohn
06/7/2012, 03/13/2015 Unknown
293 DETROL Tablets 2 mg Pharmacia and Upjohn
06/07/2012, 03/13/2015 Unknown
294 DETROL LA Extended-release Capsules
4 mg Pharmacia and Upjohn
01/02/2014 Unknown
295 DETROL LA Extended-release Capsules
2 mg Pharmacia and Upjohn
01/02/2014 Unknown
296 DEXEDRINE SPANSULE
Extended-release Capsules
15 mg Impax Laboratories, Inc.
08/02/1976 Unknown
297 DEXEDRINE SPANSULE
Extended-release Capsules
10 mg Impax Laboratories, Inc.
08/02/1976 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 298 DEXEDRINE
SPANSULE Extended-release Capsules
5 mg Impax Laboratories, Inc.
08/02/1976 Unknown
299 DIABETA Tablets 1.25 mg Sanofi-Aventis U.S., LLC
05/01/1984 Unknown
300 DIAMOX SEQUELS ER Capsules 500 mg Teva Branded Pharmaceuticals USA, Inc.
12/2008 Unknown
301 DIASTAT Gel 20 mg Valeant Pharmaceuticals North America LLC
09/03/2010 Unknown
302 DIASTAT Gel 10 mg Valeant Pharmaceuticals North America LLC
09/03/2010 Unknown
303 DIASTAT Gel 2.5 mg Valeant Pharmaceuticals North America LLC
10/01/2010 Unknown
304 DIAZEPAM Gel 20 mg Valeant Pharmaceuticals North America, LLC
09/03/2010 Unknown
305 DIAZEPAM Gel 10 mg Valeant Pharmaceuticals North America, LLC
09/03/2010 Unknown
306 DIAZEPAM Gel 2.5 mg Valeant Pharmaceuticals
09/03/2010 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing North America, LLC
307 DIBENZYLINE Capsules 10 mg Concordia Pharmaceuticals Inc.
08/11/2015 Unknown
308 DIFFERIN GEL 0.1% Gel 0.1% Galderma Laboratories, L.P.
08/23/2010 Unknown
309 DIFFERIN GEL 0.3% Gel 0.3% Galderma Laboratories, L.P.
01/2014 Unknown
310 DIFFERIN GEL 0.3% Gel 0.3% Galderma Laboratories, L.P.
09/2009 Unknown
311 DIFFERIN LOTION 0.1%
Lotion 0.1% Galderma Laboratories, L.P.
03/2010 Unknown
312 DIFLUCAN Powder for Oral Suspension
10 mg/mL when reconstituted
Pfizer Inc. 03/12/2004 Unknown
313 DIFLUCAN Powder for Oral Suspension
40 mg/mL when reconstituted
Pfizer Inc. 03/12/2004 Unknown
314 DIFLUCAN Tablets 50 mg Pfizer Inc. 03/12/2004 Unknown 315 DIFLUCAN Tablets 100 mg Pfizer Inc. 03/12/2004 Unknown 316 DIFLUCAN Tablets 150 mg Pfizer Inc. 03/12/2004 Unknown 317 DIFLUCAN Tablets 200 mg Pfizer Inc. 03/12/2004 Unknown 318 DILANTIN Tablet
(INFATABS) 50 mg Parke-Davis Division
of Pfizer Inc. 12/27/2012 Unknown
319 DILANTIN-125 Oral 125 mg/5 mL (237 mL Parke-Davis Division 6/13/2012 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Suspension bottle) of Pfizer Inc.
320 DILAUDID Solution 5 mg/5 mL (1 mg/mL) Rhodes Pharmaceuticals L.P.
10/1/2012 Unknown
321 DILAUDID Tablets 4 mg Rhodes Pharmaceuticals L.P.
11/23/2009 Unknown
322 DILAUDID Tablets 8 mg Rhodes Pharmaceuticals L.P.
11/23/2009 Unknown
323 DILAUDID Tablets 2 mg Rhodes Pharmaceuticals L.P.
11/23/2009 Unknown
324 DIPROLENE Ointment 0.05% Merck Sharp & Dohme Corporation
8/10/2012 Unknown
325 DITROPAN XL Extended-release Tablets
5 mg Janssen Research and Development, LLC
11/12/2015 Unknown
326 DITROPAN XL Extended-release Tablets
10 mg Janssen Research and Development, LLC
11/12/2015 Unknown
327 DIURIL Injection 500 mg/vial, sterile lyophilized
Oak Pharmaceuticals Inc.
08/13/2012 Unknown
328 DOLOPHINE Tablets 10 mg West-Ward Pharmaceuticals Corp.
1999 - 2000 Unknown
329 DOLOPHINE Tablets 5 mg West-Ward Pharmaceuticals Corp.
1999 - 2000 Unknown
330 DORAL Tablets 15 mg Galt Pharmaceuticals, LLC
8/8/13 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 331 DORIBAX Powder for
Injection 500 mg/vial Shionogi Inc. 12/2016 Unknown
332 DORIBAX Powder for Injection
250 mg/vial Shionogi Inc. 12/2016 Unknown
333 DORYX Delayed-Release Tablets
150 mg Mayne Pharma International Pty Ltd.
07/08/2013 Unknown
334 DORYX Delayed-Release Tablets
100 mg Mayne Pharma International Pty Ltd.
07/08/2013 Unknown
335 DORYX Delayed-Release Tablets
75 mg Mayne Pharma International Pty Ltd.
07/08/2013 Unknown
336 DORYX Delayed-Release Tablets
200 mg Mayne Pharma International Pty Ltd.
2016 Unknown
337 DORYX Delayed-Release Tablets
50 mg Mayne Pharma International Pty Ltd.
Unknown Unknown
338 DOSTINEX Tablets 0.5 mg Pharmacia and Upjohn
09/22/2014 Unknown
339 DOVONEX Cream 0.005% LEO Pharma Inc. 2012 Unknown 340 DOVONEX Ointment 0.005% LEO Pharma Inc. 07/01/2013 Unknown 341 DOXIL Injection
(Liposomal 20 mg/10 mL single use vial
Janssen Research & Development, LLC
07/2017 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing formulation)
342 DOXIL Injection (Liposomal formulation)
50 mg/25 mL single use vial
Janssen Research & Development, LLC
07/2017 Unknown
343 DOXORUBICIN Injection 50 mg/25 mL Pharmacia and Upjohn
03/17/2014 Unknown
344 DOXORUBICIN Injection 20 mg/10mL Pharmacia and Upjohn
03/17/2014 Unknown
345 DOXORUBICIN Injection 10 mg/5 mL Pharmacia and Upjohn
03/17/2014 Unknown
346 DOXORUBICIN Injection 200 mg/ 100 mL Pharmacia and Upjohn
03/17/2014 Unknown
347 DOXORUBICIN Injection 150 mg/75 mL Pharmacia and Upjohn
4/1/2013 Unknown
348 DOXORUBICIN Injection 50 mg/25 mL Pharmacia and Upjohn
4/1/2013 Unknown
349 DOXORUBICIN Injection 20 mg/10 mL Pharmacia and Upjohn
4/1/2013 Unknown
350 DOXORUBICIN Injection 10 mg/5 mL Pharmacia and Upjohn
4/1/2013 Unknown
351 DOXORUBICIN Injection 200 mg/100 mL Pharmacia and Upjohn
4/1/2013 Unknown
352 DRISDOL Capsules 1.25 mg (50,000 IU) Sanofi Aventis US LLC
11/10/2009 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 353 DUAC Topical Gel 1.2% Clindamycin
Phosphate, 5% Benzoyl Peroxide
Stiefel Laboratories, Inc.
06/27/2012 Unknown
354 DUETACT Tablets 30 mg / 2 mg Takeda Pharmaceuticals U.S.A., Inc.
08/04/2015 Unknown
355 DUETACT Tablets 30 mg / 4 mg Takeda Pharmaceuticals U.S.A., Inc.
08/04/2015 Unknown
356 DURAGESIC-100 Transdermal System
100 mcg/h Janssen Research & Development, LLC
2009 Unknown
357 DURAGESIC-12 Transdermal System
12 mcg/h Janssen Research & Development, LLC
2009 Unknown
358 DURAGESIC-25 Transdermal System
25 mcg/h Janssen Research & Development, LLC
2009 Unknown
359 DURAGESIC-50 Transdermal System
50 mcg/h Janssen Research & Development, LLC
2009 Unknown
360 DURAGESIC-75 Transdermal System
75 mcg/h Janssen Research & Development, LLC
2009 Unknown
361 DUTOPROL Tablets 25/12.5 mg Concordia Pharmaceuticals Inc.
08/2017 Unknown
362 DUTOPROL Tablets 100/12.5 mg Concordia Pharmaceuticals Inc.
08/2017 Unknown
363 EDECRIN Tablets 25 mg Aton Pharma, Inc. 01/2016 - 01/2017 Unknown 364 EFFEXOR XR Extended- 150 mg Wyeth 6/1/2008 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing release Capsules
Pharmaceuticals
365 EFFEXOR XR Extended-release Capsules
37.5 mg Wyeth Pharmaceuticals
6/1/2008 Unknown
366 EFFEXOR XR Extended-release Capsules
75 mg Wyeth Pharmaceuticals
6/1/2008 Unknown
367 EFUDEX Cream 5% Topical Cream Valeant Pharmaceuticals International, Inc.
09/2006 Unknown
368 ELDEPRYL Capsules 5 mg Somerset Pharmaceuticals, Inc.
05/1998 - 05/1999 Unknown
369 ELDEPRYL Tablets 5 mg Somerset Pharmaceuticals, Inc.
06/1999 - 06/2000 Unknown
370 ELOXATIN Injection 100 mg / 20 mL (5 mg/mL)
Sanofi-Aventis US LLC
07/07/2014 Unknown
371 ELOXATIN Injection 50 mg / 10 mL (5 mg/mL) Sanofi-Aventis US LLC
07/07/2014 Unknown
372 ELOXATIN (PREMIERPro)
Injection 100 mg / 20 mL (5 mg/mL)
Sanofi-Aventis US LLC
10/2015 Unknown
373 ELOXATIN (PREMIERPro)
Injection 50 mg/10 mL (5 mg/mL) Sanofi-Aventis US LLC
10/2015 Unknown
374 EMLA Cream 2.5% and 2.5% Actavis Laboratories UT, Inc.
11/12/2012 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 375 ENTOCORT EC Capsules 3 mg Paddock Laboratories,
LLC 08/18/2011 Unknown
376 EPIDUO Topical Gel 0.1% / 2.5% Galderma Laboratories, L.P.
08/2017 Unknown
377 EPIPEN Injection 0.3 mg/0.3 mL Mylan Specialty L.P. 12/15/2016 Unknown 378 EPIPEN JR. Injection 0.15/0.3 mL Mylan Specialty L.P. 12/15/2016 Unknown 379 EPIVIR-HBV Tablets 100 mg GlaxoSmithKline 09/05/2014 Unknown 380 EPZICOM Tablets 600 mg and 300 mg ViiV Healthcare
Company 09/2016 Unknown
381 ERYC Delayed-Release Capsules
250 mg Mayne Pharma International Pty Ltd
07/29/2013 Unknown
382 ERYGEL Topical Gel 2% Mylan Pharmaceuticals, Inc.
07/2015 Unknown
383 ERYPED Granule 200 mg per 5 mL when reconstituted
Arbor Pharmaceuticals LLC
09/2016 Unknown
384 EVISTA Tablets 60 mg Eli Lilly and Company
03/01/2014 Unknown
385 EXALGO Extended-release Tablets
8 mg Mallinckrodt Pharmaceuticals
06/12/2014 Unknown
386 EXALGO Extended-release Tablets
12 mg Mallinckrodt Inc. 06/12/2014 Unknown
387 EXALGO Extended-release Tablets
16 mg Mallinckrodt Inc. 06/12/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 388 EXALGO Extended-
release Tablets 32 mg Mallinckrodt Inc. 06/12/2014 Unknown
389 EXELON Capsule 1.5 mg Novartis Pharmaceuticals Corp.
07/1/2010 Unknown
390 EXELON Capsule 3 mg Novartis Pharmaceuticals Corp.
07/1/2010 Unknown
391 EXELON Capsule 4.5 mg Novartis Pharmaceuticals Corp.
07/1/2010 Unknown
392 EXELON Capsule 6 mg Novartis Pharmaceuticals Corp.
07/1/2010 Unknown
393 EXFORGE Tablets 10 mg/320 mg Novartis Pharmaceutical Corp.
03/2015 Unknown
394 EXFORGE Tablets 10 mg/160 mg Novartis Pharmaceutical Corp.
03/2015 Unknown
395 EXFORGE Tablets 5 mg/160 mg Novartis Pharmaceutical Corp.
03/2015 Unknown
396 EXFORGE Tablets 5 mg/320 mg Novartis Pharmaceutical Corp.
03/2015 Unknown
397 EXFORGE HCT Tablets 5 mg/160 mg/12.5 mg (each tablet contains 6.9 mg amlodipine besylate)
Novartis Pharmaceutical Corporation
12/02/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 398 EXFORGE HCT Tablets 10 mg/160 mg/25 mg
(each tablet contains 13.9 mg amlodipine besylate)
Novartis Pharmaceutical Corporation
12/02/2014 Unknown
399 EXFORGE HCT Tablets 5 mg/160 mg/25 mg (each tablet contains 6.9 mg amlodipine besylate)
Novartis Pharmaceutical Corporation
12/02/2014 Unknown
400 EXFORGE HCT Tablets 10 mg/160 mg/12.5 mg (each tablet contains 13.9 mg amlodipine besylate)
Novartis Pharmaceutical Corporation
12/02/2014 Unknown
401 EXFORGE HCT Tablets 10 mg/320 mg/25 mg (each tablet contains 13.9 mg amlodipine besylate)
Novartis Pharmaceutical Corporation
12/02/2014 Unknown
402 FAMVIR Tablets 125 mg Novartis 03/22/2011 Unknown 403 FAMVIR Tablets 250 mg Novartis 03/22/2011 Unknown 404 FAMVIR FAMVIR Tablets 500 mg Novartis 03/22/2011 Unknown 405 FAZACLO Orally
Disintegrating Tablets
100 mg Jazz Pharmaceuticals 8/30/2012 Unknown
406 FAZACLO Orally Disintegrating Tablets
12.5 mg Jazz Pharmaceuticals 8/30/2012 Unknown
407 FAZACLO Orally Disintegrating Tablets
25 mg Jazz Pharmaceuticals 8/30/2012 Unknown
408 FELBATOL Oral 600 mg/5 mL Meda 1/2012 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Suspension Pharmaceuticals
409 FELBATOL Tablets 600 mg Meda Pharmaceuticals
11/2011 Unknown
410 FELBATOL Tablets 400 mg Meda Pharmaceuticals
11/2011 Unknown
411 FELDENE Capsules 10 mg Pfizer Inc. 03/03/2014 Unknown 412 FELDENE Capsules 20 mg Pfizer Inc. 03/03/2014 Unknown 413 FEMCON Fe Chewable
Tablets 0.4 mg/35 mcg Allergan
Pharmaceuticals International Ltd.
10/2011 Unknown
414 FENOGLIDE Tablets 40 mg Santarus, Inc. 06/24/2015 Unknown 415 FENOGLIDE Tablets 120 mg Santarus, Inc. 06/24/2015 Unknown 416 FIBRICOR Tablets 105 mg Aralez
Pharmaceuticals US, Inc.
09/22/2010 Unknown
417 FIBRICOR Tablets 35 mg Aralez Pharmaceuticals US, Inc.
09/22/2010 Unknown
418 FIORICET with CODEINE
Capsules 50 mg / 325 mg / 40 mg / 30 mg
Actavis Laboratories UT, Inc.
10/01/2003 Unknown
419 FIORINAL Capsules 50 mg / 325 mg / 40 mg Allergan Sales, LLC 10/6/2003 Unknown 420 FIORINAL with
CODEINE Capsules 50 mg / 325 mg / 40 mg /
30 mg Allergan Sales, LLC 10/26/2006 Unknown
421 FLORONE Cream 0.05% Pharmacia and Prior to 1/1/1999 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Upjohn Company
422 FLUMADINE Tablets 100 mg Forest Laboratories, Inc.
09/2002 - 09/2003 Unknown
423 FLUOXETINE Tablets 60 mg Alvogen Group Holdings 3, LLC
09/2017 Unknown
424 FML Ophthalmic Suspension
0.1% Allergan, Inc. 10/1997 Unknown
425 FOCALIN XR Extended-release Capsules
15 mg Novartis Pharmaceuticals Corporation
03/04/2014 Unknown
426 FOCALIN XR Extended-release Capsules
5 mg Novartis Pharmaceuticals Corporation
11/12/2014 Unknown
427 FOCALIN XR Extended-release Capsules
10 mg Novartis Pharmaceuticals Corporation
02/03/2015 Unknown
428 FOCALIN XR Extended-release Capsules
40 mg Novartis Pharmaceuticals Corporation
03/04/2014 Unknown
429 FOCALIN XR Extended-release Capsules
30 mg Novartis Pharmaceuticals Corporation
03/04/2014 Unknown
430 FORTESA Gel 10 mg testosterone/actuation
Endo Pharmaceuticals, Inc.
08/25/2014 Unknown
431 FURADANTIN Oral 25 mg / 5 mL Casper Pharma LLC 12/2011 - 12/2012 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Suspension
432 GABITRIL Tablets 4 mg Cephaloln, Inc. 12/26/2012 Unknown 433 GABITRIL Tablets 2 mg Cephalon, Inc 12/26/2012 Unknown 434 GASTROCROM Oral
Concentrate 100 mg/5 mL (ampule) Wallace
Pharmaceuticals Inc. 06/2015 Unknown
435 GENERESS FE Chewable Tablets
0.8 mg/25 mcg Allergan Pharmaceuticals International Ltd.
03/2015 Unknown
436 GEODON Capsules 40 mg Pfizer 12/15/2011 Unknown 437 GEODON Capsules 80 mg Pfizer 12/15/2011 Unknown 438 GEODON Capsules 60 mg Pfizer 12/15/2011 Unknown 439 GEODON Capsules 20 mg Pfizer 12/15/2011 Unknown 440 GLUCOTROL XL Extended-
release Tablets 2.5 mg Pfizer Inc. 03/11/2004 Unknown
441 GLUCOTROL XL Extended-release Tablets
5 mg Pfizer Inc. 03/11/2004 Unknown
442 GLUCOTROL XL Extended-release Tablets
10 mg Pfizer Inc. 03/11/2004 Unknown
443 GOLYTELY Powder for Oral Solution
PEG-3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L
Braintree Laboratories, Inc.
07/2009 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing (per 4 liter jug w/water)
444 GRIS-PEG Tablets 125 mg Valeant Pharmaceuticals International Inc.
12/03/2012 Unknown
445 GRIS-PEG Tablets 250 mg Valeant Pharmaceuticals International Inc.
12/03/2012 Unknown
446 HALCION Tablets 0.25 mg Pharmacia and Upjohn Company
6/17/2003 Unknown
447 HALCION Tablets 0.125 mg Pharmacia and Upjohn Company
7/11/2003 Unknown
448 HALDOL Injection 5 mg/mL Janssen Pharmaceuticals, Inc.
7/2011 Unknown
449 HALDOL DECANOATE
Injection 50 mg/mL Janssen Research & Development, LLC
08/2011 Unknown
450 HALDOL DECANOATE
Injection 100 mg/mL Janssen Research & Development, LLC
07/2011 Unknown
451 HECTOROL Capsules, liquid filled
2.5 mcg Genzyme Corporation
03/11/2014 Unknown
452 HECTOROL Capsules, liquid filled
1 mcg Genzyme Corporation
03/11/2014 Unknown
453 HECTOROL Capsules, liquid filled
0.5 mcg Genzyme Corporation
03/11/2014 Unknown
454 HIPREX Tablets 1 g Validus Pharmaceuticals LLC
06/2016 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 455 IMITREX Injection 4 mg/0.5 mL (Kit) GlaxoSmithKline
Intellectual Property Ltd. England
03/29/2012 Unknown
456 IMITREX Injection 4 mg/0.5 mL GlaxoSmithKline Intellectual Property Ltd. England
3/29/2012 Unknown
457 IMITREX Injection 6 mg/0.5 mL Statdose kit GlaxoSmithKline Intellectual Property Ltd. England
03/29/2012 Unknown
458 IMITREX Injection 6 mg/0.5 mL (Kit) GlaxoSmithKline Intellectual Property Ltd. England
11/2007 - 11/2008 Unknown
459 IMITREX Injection 6 mg/0.5 mL GlaxoSmithKline Intellectual Property Ltd. England
11/2007 - 11/2008 Unknown
460 IMITREX Nasal Spray 5 mg GlaxoSmithKline Intellectual Property Ltd. England
10/13/2008 Unknown
461 IMITREX Nasal Spray 20 mg GlaxoSmithKline Intellectual Property Ltd. England
10/03/2008 Unknown
462 INDERAL LA Extended-release Capsules
60 mg ANI Pharmaceuticals, Inc.
2/25/2009 Unknown
463 INDERAL LA Extended- 80 mg ANI Pharmaceuticals, 2/25/2009 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing release Capsules
Inc.
464 INDERAL LA Extended-release Capsules
120 mg ANI Pharmaceuticals, Inc.
2/25/2009 Unknown
465 INDERAL LA Extended-release Capsules
160 mg ANI Pharmaceuticals, Inc.
2/25/2009 Unknown
466 INSPRA Tablets 25 mg GD Searle LLC 09/13/2007 Unknown 467 INSPRA Tablets 50 mg GD Searle LLC 09/13/2007 Unknown 468 INVEGA Extended-
release Tablets 6 mg Janssen Research &
Development, LLC 09/24/2015 Unknown
469 INVEGA Extended-release Tablets
1.5 mg Janssen Research & Development, LLC
09/24/2015 Unknown
470 INVEGA Extended-release Tablets
3 mg Janssen Research & Development, LLC
09/24/2015 Unknown
471 INVEGA Extended-release Tablets
9 mg Janssen Research & Development, LLC
09/24/2015 Unknown
472 IOPIDINE Ophthalmic Solution
0.5% Alcon Research, Ltd. 08/2009 Unknown
473 ISOPTO CARPINE Ophthalmic Solution
4% Novartis Pharmaceuticals Corporation
02/21/1996 Unknown
474 ISOPTO CARPINE Ophthalmic Solution
1% Novartis Pharmaceuticals
02/21/1996 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Corporation
475 ISOPTO CARPINE Ophthalmic Solution
2% Novartis Pharmaceuticals Corporation
02/21/1996 Unknown
476 JALYN Capsules 0.5 mg/0.4 mg GlaxoSmithKline LLC
07/2016 Unknown
477 KADIAN Extended-release Capsules
30 mg Allergan Sales, LLC 7/2012 - 7/2013 Unknown
478 KADIAN Extended-release Capsules
80 mg Allergan Sales, LLC 7/2012 - 7/2013 Unknown
479 KADIAN Extended-release Capsules
60 mg Allergan Sales, LLC 7/2012 - 7/2013 Unknown
480 KADIAN Extended-release Capsules
20 mg Allergan Sales, LLC 7/2012 - 7/2013 Unknown
481 KADIAN Extended-release Capsules
200 mg Allergan Sales, LLC 11/11/2011 Unknown
482 KADIAN Extended-release Capsules
100 mg Allergan Sales, LLC 11/11/2011 Unknown
483 KADIAN Extended- 80 mg Allergan Sales, LLC 11/11/2011 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing release Capsules
484 KADIAN Extended-release Capsules
50 mg Allergan Sales, LLC 11/11/2011 Unknown
485 KADIAN Extended-release Capsules
20 mg Allergan Sales, LLC. 11/11/2011 Unknown
486 KADIAN Extended-release Capsules
30 mg Allergan Sales, LLC 11/11/2011 Unknown
487 KADIAN Extended-release Capsules
60 mg Allergan Sales, LLC 11/11/2011 Unknown
488 KADIAN Extended-release Capsules
100 mg Allergan Sales, LLC 7/2012 - 7/2013 Unknown
489 KADIAN Extended-release Capsules
50 mg Allergan Sales, LLC 7/2012 - 7/2013 Unknown
490 KADIAN Extended-release Capsules
10 mg Allergan Sales, LLC 11/11/2011 Unknown
491 KAPVAY Extended-release Tablets
0.1 mg Concordia Pharmaceuticals, Inc.
06/2016 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 492 KAZANO Tablets 12.5 mg/1000 mg Takeda U.S.A. Inc. 04/2016 Unknown 493 KAZANO Tablets 12.5 mg/500 mg Takeda U.S.A. Inc. 04/2016 Unknown 494 K-DUR 10 Extended-
release Tablets 10 mEq Schering Corporation 06/2002 - 06/2003 Unknown
495 K-DUR 20 Extended-release Tablets
20 mEq Schering Corporation 06/1998 - 06/1999 Unknown
496 KEFLEX Capsules 750 mg Pragma Pharmaceuticals, LLC
06/2017 Unknown
497 KHEDEZLA Extended-release Tablets
50 mg Osmotica Pharmaceutical Corporation
07/10/2013 Unknown
498 KHEDEZLA Extended-release Tablets
100 mg Osmotica Pharmaceutical US LLC
07/10/2013 Unknown
499 KLARON Lotion 10% Valeant Pharmaceuticals North America, LLC
12/2005 - 12/2006 Unknown
500 K-TAB Extended-release Tablets
750 mg AbbVie Inc. 02/2011 Unknown
501 K-TAB Extended-release Tablets
600 mg AbbVie Inc. 02/2011 Unknown
502 K-TAB Extended-release Tablets
1500 mg AbbVie Inc. 01/2014 Unknown
503 LAC-HYDRIN Cream eq. 12% base Bristol-Myers Squibb 07/2004 - 06/2005 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Company
504 LAC-HYDRIN Lotion eq. 12% base Bristol-Myers Squibb Company
03/2004 - 02/2005 Unknown
505 LANOXIN Tablets 0.25 mg Concordia Pharmaceuticals Inc.
01/14/2014 Unknown
506 LANOXIN Tablets 0.125 mg Concordia Pharmaceuticals Inc.
01/14/2014 Unknown
507 LESCOL XL Extended-release Tablets
80 mg Novartis Pharmaceuticals Corporation
10/15/2015 Unknown
508 LEVO-T Tablets 150 mcg ALARA Pharmaceutical Corporation
03/2002 Unknown
509 LEVO-T Tablets 137 mcg ALARA Pharmaceutical Corporation
03/2002 Unknown
510 LEVO-T Tablets 125 mcg ALARA Pharmaceutical Corporation
03/2002 Unknown
511 LEVO-T Tablets 112 mcg ALARA Pharmaceutical Corporation
03/2002 Unknown
512 LEVO-T Tablets 100 mcg ALARA Pharmaceutical Corporation
03/2002 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 513 LEVO-T Tablets 88 mcg ALARA
Pharmaceutical Corporation
03/2002 Unknown
514 LEVO-T Tablets 50 mcg ALARA Pharmaceutical Corporation
03/2002 0781-5181-10
515 LEVO-T Tablets 75 mcg ALARA Pharmaceutical Corporation
03/2002 Unknown
516 LEVO-T Tablets 200 mcg ALARA Pharmaceutical Corporation
03/2002 Unknown
517 LEVO-T Tablets 25 mcg ALARA Pharmaceutical Corporation
03/2002 Unknown
518 LEVO-T Tablets 300 mcg ALARA Pharmaceutical Corporation
03/2002 Unknown
519 LEVO-T Tablets 175 mcg ALARA Pharmaceutical Corporation
03/2002 Unknown
520 LEXAPRO Oral Solution 5 mg / 5 mL Allergan Sales, LLC 03/26/2015 Unknown 521 LEXAPRO Tablets 5 mg Forest
Laboratories,LLC 2/29/2012 Unknown
522 LEXAPRO Tablets 20 mg Forest Laboratories, 2/29/2012 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing LLC
523 LEXAPRO Tablets 10 mg Forest Laboratories, LLC
2/29/2012 Unknown
524 LIBRAX Capsules 5 mg/2.5 mg Valeant Pharmaceuticals North America LLC
09/23/2009 Unknown
525 LIBRAX Capsules 5 mg/2.5 mg Valeant Pharmaceuticals North America LLC
09/2016 - 08/2017 Unknown
526 LIDEX Topical Solution
0.05% County Line Pharmaceuticals, LLC
04/01/2014 - 03/31/2015 Unknown
527 LIDODERM Film, Controlled Release
5% (700 mg per patch) Teikoku Pharma USA, Inc.
05/02/2016 Unknown
528 LIDODERM Patch 700 mg (50 mg per gram adhesive) in an aqueous base
Teikoku Pharma USA, Inc.
05/2014 Unknown
529 LIMBITROL Tablets 5 mg; eq. 12.5 mg base Valeant Pharmaceuticals International
01/2006 - 12/2006 Unknown
530 LIMBITROL DS Tablets 10 mg; eq. 25 mg base Valeant Pharmaceuticals International
01/2007 - 12/2007 Unknown
531 LIORESAL Injection 0.5 mg/mL Medtronic Inc 06/1999 - 05/2000 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 532 LIORESAL Injection 2 mg/mL Medtronic Inc 06/1999 - 05/2000 Unknown 533 LIPITOR Tablets 40 mg Pfizer 1/28/2013 Unknown 534 LIPITOR Tablets 20 mg Pfizer 1/28/2013 Unknown 535 LIPITOR Tablets 80 mg Pfizer 1/28/2013 Unknown 536 LIPITOR Tablets 10 mg Pfizer 1/28/2013 Unknown 537 LIPOFEN Capsules 50 mg Cipher
Pharmaceuticals, Inc. 04/2016 Unknown
538 LIPOFEN Capsules 150 mg Cipher Pharmaceuticals, Inc.
04/2016 Unknown
539 LITHOBID Extended-release Tablets
300 mg ANI Pharmaceuticals, Inc.
12/2016 Unknown
540 LOCOID Cream 0.1% Precision Dermatology, Inc.
09/2009 Unknown
541 LOCOID Cream 0.1% Precision Dermatology, Inc.
07/2013 Unknown
542 LOCOID (Ointment) Ointment 0.1% Precision Dermatology, Inc.
10/2013 - 10/2014 Unknown
543 LOCOID (Ointment) Ointment 0.1% Precision Dermatology, Inc.
10/2015 - 10/2016 Unknown
544 LOCOID (Solution) Topical Solution
0.1% Precision Dermatology, Inc.
02/1987 Unknown
545 LOCOID (Solution) Topical Solution
0.1% Precision Dermatology, Inc.
02/24/2010 Unknown
546 LOCOID Cream 0.1% Precision 07/03/2013 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing LIPOCREAM Dermatology, Inc.
547 LOCOID LIPOCREAM
Cream 0.1% Precision Dermatology, Inc
08/22/2013 Unknown
548 LODOSYN Tablets 25 mg Aton Pharma, Inc. 04/2014 Unknown 549 LOESTRIN 2 Fe Tablets 1 mg/20 mcg Allergan
Pharmaceuticals International Ltd.
11/05/2015 Unknown
550 LOMOTIL Tablet 2.5 mg/0.025 mg GD Searle 07/2011, 02/2013 Unknown 551 LOPRESSOR HCT Tablets 1 mg/mL Novartis
Pharmaceuticals Corporation
03/1998 - 03/1999 Unknown
552 LOPRESSOR HCT Tablets 50mg / 25mg Novartis Pharmaceuticals Corporation
11/25/2009 Unknown
553 LOPRESSOR HCT Tablets 100 mg / 25 mg Novartis Pharmaceuticals Corporation
11/25/2009 Unknown
554 LOPROX Cream 0.77% Medicis Pharmaceutical Corporation
12/2004 - 11/2005 Unknown
555 LOPROX Gel 0.77% County Line Pharmaceuticals, LLC
07/2007 - 06/2008 Unknown
556 LOPROX Shampoo 1% Medicis Pharmaceutical
12/2012 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Corporation
557 LOPROX Topical Suspension
0.77% Medicis Pharmaceutical Corporation
12/2003 - 11/2004 Unknown
558 LoSEASONIQUE Tablets 0.1 mg/0.02 mg and 0.01 mg
Teva Branded Pharmaceutical Products
12/07/2010 Unknown
559 LOTENSIN HCT Tablets 10 mg; 12.5 mg Validus Pharmaceuticals LLC
06/2013 - 05/2014 Unknown
560 LOTENSIN HCT Tablets 20 mg; 25 mg Validus Pharmaceuticals LLC
06/2013 - 05/2014 Unknown
561 LOTENSIN HCT Tablets 20 mg; 12.5 mg Validus Pharmaceuticals LLC
06/2013 - 05/2014 Unknown
562 LOTORNEX Tablets 0.5 mg Sebela Ireland Limited
05/2015 Unknown
563 LOTREL Capsules 2.5 mg; 10 mg Novartis Pharmaceuticals Corporation
06/11/2007 Unknown
564 LOTREL Capsules 5 mg; 10 mg Novartis Pharmaceuticals Corporation
06/11/2007 Unknown
565 LOTREL Capsules 5 mg; 20 mg Novartis Pharmaceuticals Corporation
06/11/2007 Unknown
566 LOTREL Capsules 10 mg; 20 mg Novartis 06/11/2007 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Pharmaceuticals Corporation
567 LOTREL Capsules 10 mg; 40 mg Novartis Pharmaceuticals Corporation
01/03/2011 Unknown
568 LOTREL Capsules 5 mg; 40 mg Novartis Pharmaceuticals Corporation
01/03/2011 Unknown
569 LOTRIMIN AF Cream 1% Schering-Plough HealthCare Products, Inc
03/1998 - 03/1999 Unknown
570 LOTRISONE Cream 1%/0.05% Merck Sharp & Dohme Corporation
8/16/2012 Unknown
571 LOTRONEX Tablets 1 mg Sebela Ireland Limited
05/2015 Unknown
572 LOVAZA Capsules 1 gram GlaxoSmithKline LLC
03/05/2015 Unknown
573 LOVENOX Injection 120 mg prefilled syringe Sanofi Aventis US LLC
05/2015 Unknown
574 LOVENOX Injection 120 mg/0.8 mL Sanofi Aventis US LLC
10/2011 Unknown
575 LOVENOX Injection 300 mg prefilled syringe Sanofi Aventis US LLC
03/2015 Unknown
576 LOVENOX Injection 150 mg prefilled syringe Sanofi Aventis US LLC
05/2015 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 577 LOVENOX Injection 30 mg prefilled syringe Sanofi Aventis US
LLC 03/2015 Unknown
578 LOVENOX Injection 40 mg prefilled syringe Sanofi Aventis US LLC
03/2015 Unknown
579 LOVENOX Injection 60 mg prefilled syringe Sanofi Aventis US LLC
03/2015 Unknown
580 LOVENOX Injection 80 mg prefilled syringe Sanofi Aventis US LLC
03/2015 Unknown
581 LOVENOX Injection 300 mg/3mL Sanofi Aventis US LLC
10/2011 Unknown
582 LOVENOX Injection 100 mg prefilled syringe Sanofi Aventis US LLC
03/2015 Unknown
583 LOVENOX Injection 150 mg/1 mL Sanofi Aventis US LLC
10/2011 Unknown
584 LOVENOX Injection 100 mg/1 mL Sanofi Aventis US LLC
10/2011 Unknown
585 LOVENOX Injection 40 mg/0.4 mL Sanofi Aventis US LLC
10/2011 Unknown
586 LOVENOX Injection 30 mg/0.3 mL Sanofi Aventis US LLC
10/2011 Unknown
587 LOVENOX Injection 80 mg/0.8 mL Sanofi Aventis US LLC
10/2011 Unknown
588 LOVENOX Injection 60 mg/0.6 mL Sanofi Aventis US LLC
10/2011 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 589 LOZOL Tablets 2.5 mg Rhone-Poulenc Rorer
Pharmaceuticals Inc. Prior to 1/1/1999 Unknown
590 LUVOX Tablets 25 mg ANI Pharmaceuticals, Inc.
08/09/2011 Unknown
591 LUVOX Tablets 50 mg ANI Pharmaceuticals, Inc.
08/09/2011 Unknown
592 LUVOX Tablets 100 mg ANI Pharmaceuticals, Inc.
08/09/2011 Unknown
593 LYSTEDA Tablets 650 mg Ferring Pharmaceuticals Inc.
03/17/2016 Unknown
594 LYSTEDA Tablets 650 mg Ferring Pharmaceuticals Inc.
01/03/2013 Unknown
595 MACROBID Capsules 100 mg Alvogen PB Research and Development, LLC
02/2011 Unknown
596 MACROBID Capsules 100 mg Alvogen PB Research and Development, LLC
02/2011 Unknown
597 MACRODANTIN Capsules 50 mg Alvogen PB Research and Development, LLC
08/2011 Unknown
598 MACRODANTIN Capsules 50 mg Alvogen PB Research and Development, LLC
08/2011 Unknown
599 MACRODANTIN Capsules 100 mg Alvogen PB Research 08/2011 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing and Development, LLC
600 MACRODANTIN Capsules 100 mg Alvogen PB Research and Development, LLC
08/2011 Unknown
601 MALARONE Tablets 250 mg/100 mg GlaxoSmithKline LLC
7/31/2012 Unknown
602 MARINOL Capsules 10 mg AbbVie 05/2008 - 05/2009 Unknown 603 MARINOL Capsules 5 mg AbbVie 05/2008 - 05/2009 Unknown 604 MARINOL Capsules 2.5 mg AbbVie 05/2008 - 05/2009 Unknown 605 MAXITROL Ophthalmic
Ointment 3.5 mg, 10000 units, 0.1% / gram
Alcon Laboratories, Inc.
03/04/1996 Unknown
606 MAXZIDE Tablets 75 mg and 50 mg Mylan Pharmaceuticals Inc.
Prior to 1/1/1999 Unknown
607 MAXZIDE-25 Tablets 37.5 mg and 25 mg Mylan Pharmaceuticals Inc.
Prior to 1/1/1999 Unknown
608 MEDROL Tablets 4 mg Pharmacia and Upjohn
11/16/2011 Unknown
609 MEDROL Tablets 32 mg Pharmacia and Upjohn
4/22/2013 Unknown
610 MEDROL Tablets 16 mg Pharmacia and Upjohn
4/22/2013 Unknown
611 MEDROL Tablets 8 mg Pharmacia and Upjohn
4/22/2013 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 612 MEPRON Suspension 750 mg/5mL GlaxoSmithKline
LLC 03/20/2014 Unknown
613 MESNEX Injection 100 mg/mL Baxter Healthcare Corporation
12/2003 - 12/2004 Unknown
614 MESTINON Tablets 60 mg Valeant Pharmaceuticals North America, LLC
04/2002 - 03/2003 Unknown
615 MESTINON TIMESPAN
Tablets 180 mg Valeant Pharmaceuticals North America, LLC
11/2015 Unknown
616 METADATE CD Extended-release Capsules
30 mg UCB, Inc. 09/2012 Unknown
617 METADATE CD Extended-release Capsules
10 mg UCB, Inc. 09/2012 Unknown
618 METADATE CD Extended-release Capsules
40 mg UCB, Inc. 09/2012 Unknown
619 METADATE CD Extended-release Capsules
60 mg UCB, Inc. 09/2012 Unknown
620 METADATE CD Extended-release Capsules
50 mg UCB, Inc. 09/2012 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 621 METADATE CD Extended-
release Capsules
20 mg UCB, Inc. 09/2012 Unknown
622 METHYLIN Oral Solution 10 mg/5 mL Mallinckrodt Inc. 08/01/2013 Unknown 623 METHYLIN Oral Solution 5 mg/5 mL Mallinckrodt Inc. 08/01/2013 Unknown 624 METROCREAM Cream 0.75% Galderma
Laboratories, L.P. 03/2015 Unknown
625 METROCREAM Cream 0.75% Galderma Laboratories, L.P.
3/2009 Unknown
626 METROGEL Gel 0.75% Galderma Laboratories, L.P.
03/2014 Unknown
627 METROGEL Gel 0.75% Galderma Laboratories, L.P.
03/2014 Unknown
628 METROGEL Gel 1% Galderma Laboratories, L.P.
06/2005 Unknown
629 METROGEL Gel 1% Galderma Laboratories, L.P.
02/2017 Unknown
630 METROGEL-VAGINAL
Vaginal Gel 0.75% Medicis Pharmaceuticals, a Div. Of Valeant Pharmaceuticals North America LLC
04/01/2015 Unknown
631 METROLOTION Lotion 0.75% Galderma Laboratories, L.P.
6/16/2009 Unknown
632 MIACALCIN Nasal Spray 200 I.U. per actuation Sebela Ireland Ltd. 12/09/2008 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 633 MICARDIS Tablets 40 mg Boehringer Ingelheim
Pharmaceuticals, Inc. 11/13/2013 Unknown
634 MICARDIS Tablets 20 mg Boehringer Ingelheim Pharmaceuticals, Inc.
11/13/2013 Unknown
635 MICARDIS Tablets 80 mg Boehringer Ingelheim Pharmaceuticals, Inc.
11/13/2013 Unknown
636 MICARDIS HCT Tablets 40 mg/12.5 mg Boehringer Ingelheim Pharmaceuticals, Inc.
02/28/2014 Unknown
637 MICARDIS HCT Tablets 80 mg/12.5 mg Boehringer Ingelheim Pharmaceuticals, Inc.
02/28/2014 Unknown
638 MICARDIS HCT Tablets 80 mg/25 mg Boehringer Ingelheim Pharmaceuticals, Inc.
02/28/2014 Unknown
639 MICRO-K EXTENCAPS
Extended-Release Capsules
8 mEq (600 mg) Nesher Pharmaceuticals USA LLC
03/10/2011 Unknown
640 MICRO-K EXTENCAPS
Extended-Release Capsules
10 mEq (750 mg) Nesher Pharmaceuticals USA LLC
01/19/2011 Unknown
641 MICRONASE Tablets 2.5 mg Pharmacia and Upjohn
Prior to 1/1/1999 Unknown
642 MICRONASE Tablets 5 mg Pharmacia and Upjohn
Prior to 1/1/1999 Unknown
643 MICROZIDE Capsules 12.5 mg Allergan Sales, LLC 10/05/2001 Unknown 644 MIDAMOR Tablets 5 mg Paddock Laboratories 04/06/2009 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 645 MIGRANAL Nasal Spray 4 mg in 1 mL Valeant
Pharmaceuticals North America, LLC
03/18/2013 Unknown
646 MINIPRESS Capsules 1 mg Pfizer Inc. 01/2017 Unknown 647 MINIPRESS Capsules 2 mg Pfizer Inc. 01/2017 Unknown 648 MINIPRESS Capsules 5 mg Pfizer Inc. 01/2017 Unknown 649 MITIGARE Capsules 0.6 mg Hikma International
Pharmaceuticals LLC 10/01/2014 Unknown
650 MOBIC Oral Suspension
7.5 mg/5 mL Boehringer Ingelheim Pharmaceuticals Inc.
6/12/2006 Unknown
651 MONODOX Capsules eq. 50 mg base Watson Laboratories, Inc.
02/07/2005 Unknown
652 MONODOX Capsules eq. 100 mg base Watson Laboratories, Inc.
02/07/2005 Unknown
653 MONOKET Tablets 10 mg Kremers Urban Pharmaceuticals, Inc.
06/30/1996 - 06/29/1997 Unknown
654 MONOKET Tablets 20 mg Kremers Urban Pharmaceuticals, Inc.
06/30/1996 - 06/29/1997 Unknown
655 MOXATAG Extended-Release Tablets
775 mg Vernalis (R&D) Limited
08/20/2014 Unknown
656 MS CONTIN Extended-release Tablets
15 mg Purdue Pharma L.P. 05/2005 - 05/2006 Unknown
657 MS CONTIN Extended- 30 mg Purdue Pharma L.P. 05/2005 - 05/2006 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing release Tablets
658 MS CONTIN Extended-release Tablets
60 mg Purdue Pharma L.P. 05/2005 - 05/2006 Unknown
659 MS CONTIN Extended-release Tablets
100 mg Purdue Pharma L.P. 05/2005 - 05/2006 Unknown
660 MS CONTIN Extended-release Tablets
200 mg Purdue Pharma L.P. 05/2005 - 05/2006 Unknown
661 MYAMBUTOL Tablets 100 mg STI Pharma LLC 12/15/2006 Unknown 662 MYAMBUTOL Tablets 400 mg STI Pharma LLC 12/15/2006 Unknown 663 MYCOBUTIN Capsules 150 mg Pharmacia and
Upjohn Company 05/13/2014 Unknown
664 NAFTIN CREAM Cream emulsion
1% Merz Pharmaceuticals, LLC
06/01/2015 Unknown
665 NAFTIN CREAM Cream emulsion
2% Merz Pharmaceuticals, LLC
06/01/2015 Unknown
666 NALFON Capsules 400 mg Xsprire Pharma 08/05/2015 Unknown 667 NAMENDA Tablets 5 mg Forest Laboratories,
LLC 04/01/2015 Unknown
668 NAMENDA Tablets 10 mg Forest Laboratories, LLC
04/01/2015 Unknown
669 NAMENDA Tablets 5 mg and 10 mg (titration pak)
Forest Laboratories, LLC
04/01/2015 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 670 NAPRELAN Controlled-
Release Tablets
500 mg Alvogen PB Research and Development LLC
03/2015 Unknown
671 NAPRELAN Controlled-Release Tablets
375 mg Alvogen PB Research and Development LLC
09/2015 Unknown
672 NARDIL Tablet 15 mg Parke-Davis 3/23/2011 Unknown 673 NASACORT AQ Nasal Spray
Spray Bottle 55 mcg/spray Sanofi Aventis US,
LLC 06/15/2011 Unknown
674 NASONEX Suspension 50 mcg Merck Sharp & Dohme Corporation
03/25/2016 Unknown
675 NATROBA Topical Suspension
0.9% ParaPRO LLC 06/2014 Unknown
676 NEOPROFEN Injection 10 mg/mL Recordati Rare Diseases Inc.
04/2016 Unknown
677 NESINA Tablets 25 mg Takeda U.S.A. Inc. 04/2016 Unknown 678 NESINA Tablets 12.5 mg Takeda U.S.A. Inc. 04/2016 Unknown 679 NESINA Tablets 6.25 mg Takeda U.S.A. Inc. 04/2016 Unknown 680 NEURONTIN Capsules 100 mg Pfizer Inc. 3/17/2004 Unknown 681 NEURONTIN Capsules 300 mg Pfizer Inc. 03/17/2004, 06/19/2009 Unknown 682 NEURONTIN Capsules 400 mg Pfizer Inc. 3/17/2004 Unknown 683 NEURONTIN Oral Solution 250 mg per 5 mL Pfizer Inc. 3/24/2011 Unknown 684 NEURONTIN Tablets 600 mg Pfizer Inc. 3/17/2004 Unknown 685 NEURONTIN Tablets 800 mg Pfizer Inc. 3/17/2004 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 686 NIASPAN Extended-
release Tablets 750 mg AbbVie 06/30/2014 Unknown
687 NIASPAN Extended-release Tablets
500 mg AbbVie 06/30/2014 Unknown
688 NIASPAN Extended-release Tablets
1000 mg AbbVie 06/30/2014 Unknown
689 NICORETTE Chewing Gum 2 mg GlaxoSmithKline Consumer Healthcare L.P.
01/2002 - 01/2003 Unknown
690 NICORETTE Chewing Gum 4 mg GlaxoSmithKline Consumer Healthcare L.P.
06/2001 - 06/2002 Unknown
691 NITROLINGUAL PUMPSPRAY
Lingual Spray 400 mcg per Spray G. Pohl-Boskamp GmbH & Co. Arbor Pharmaceuticals
02/01/2011 Unknown
692 NITROMIST Lingual Aerosol
400 mcg/spray Mist Pharmaceuticals, LLC
10/16/2012 Unknown
693 NITROSTAT Tablets 0.6 mg Pfizer Pharmaceuticals Ltd.
08/26/2016 Unknown
694 NITROSTAT Tablets 0.4 mg Pfizer Pharmaceuticals Ltd.
08/26/2016 Unknown
695 NITROSTAT Tablets 0.3 mg Pfizer Pharmaceuticals Ltd.
08/26/2016 Unknown
696 NIZORAL Shampoo 2% Janssen Research & Development, LLC
08/10/2005 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 697 NORFLEX Extended-
release Tablets 100 mg 3M Pharmaceuticals Prior to 1/1/1999 Unknown
698 NORINYL Tablets 1.0 mg / 0.05 mg Actavis Laboratories UT, Inc.
02/22/2007 Unknown
699 NORPRAMIN Tablets 10 mg Sanofi-Aventis US LLC
04/2014 Unknown
700 NORPRAMIN Tablets 150 mg Sanofi-Aventis US LLC
04/2014 Unknown
701 NORPRAMIN Tablets 25 mg Sanofi-Aventis US LLC
04/2014 Unknown
702 NORPRAMIN Tablets 50 mg Sanofi-Aventis US LLC
Prior to 1/1/1999 Unknown
703 NORPRAMIN Tablets 75 mg Sanofi-Aventis US LLC
04/2014 Unknown
704 NORPRAMIN Tablets 100 mg Sanofi-Aventis US LLC
04/2014 Unknown
705 NOR-QD Tablets 0.35 mg Actavis Laboratories UT, Inc.
06/06/2003 Unknown
706 NORVASC Tablets 2.5 mg Pfizer Inc. 4/16/2007; 6/15/2006 Unknown 707 NORVASC Tablets 5 mg Pfizer Inc. 4/16/2007; 6/15/2006 Unknown 708 NORVASC Tablets 10 mg Pfizer Inc. 4/16/2007; 6/15/2006 Unknown 709 NULYTELY Powder (for
reconstitution with water)
Per 4 liter jug: polyethylene glycol 3350 420 g, sodium bicarbonate
Braintree Laboratories, Inc.Y
02/2013 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g, flavoring 2 g
710 OCUFEN Ophthalmic Solution
0.03 % Allergan, Inc 05/2007 Unknown
711 OLUX Foam 0.05% Mylan Pharmaceuticals Inc.
02/2014 Unknown
712 OLUX-E Emulsion, Aerosol Foam
0.05% Mylan Pharmaceuticals Inc.
01/2014 Unknown
713 OMNIPRED Ophthalmic Suspension
1% Alcon Pharmaceuticals Ltd. / Alcon Research Ltd.
01/1995 Unknown
714 OPANA Tablets 5 mg Endo Pharmaceuticals, Inc.
09/29/2010 Unknown
715 OPANA Tablets 10 mg Endo Pharmaceuticals, Inc.
09/29/2010 Unknown
716 OPTIVAR Ophthalmic Solution
0.05% Meda Pharmaceuticals, Inc.
03/10/2011 Unknown
717 ORACEA Capsules 40 mg Galderma Laboratories, L.P.
04/2015 Unknown
718 ORAPRED ODT Orally Disintegrating Tablets
10 mg Concordia Pharmaceuticals Inc.
10/2015 Unknown
719 ORAPRED ODT Orally Disintegrating
15 mg Concordia Pharmaceuticals Inc.
10/2015 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Tablets
720 ORAPRED ODT Orally Disintegrating Tablets
30 mg Concordia Pharmaceuticals Inc.
10/2015 Unknown
721 ORTHO CYCLEN-28 Tablets 0.25/0.035 mg Janssen Research & Development, LLC
01/2003 Unknown
722 ORTHO MICRONOR Tablets 0.35 mg Janssen Research and Development LLC
06/2003 Unknown
723 ORTHO TRI-CYCLEN
Tablets 0.180/0.035 mg; 0.215/0.035 mg; 0.250/0.035 mg
Janssen Research and Development, LLC
9/2003 Unknown
724 ORTHO TRI-CYCLEN LO
Tablets 0.180/0.025 mg; 0.215/0.025 mg; 0.250/0.025 mg
Janssen Research and Development, LLC
01/04/2016 Unknown
725 ORTHO-NOVUM 7/7/7
Tablets 0.5 mg and 0.035 mg Janssen Research & Development, LLC
11/11/2002 Unknown
726 OSENI Tablets 25 mg/15 mg Takeda U.S.A. Inc. 04/2016 Unknown 727 OSENI Tablets 12.5 mg/15 mg Takeda U.S.A. Inc. 04/2016 Unknown 728 OSENI Tablets 25 mg/45 mg Takeda U.S.A. Inc. 04/2016 Unknown 729 OSENI Tablets 25 mg/30 mg Takeda U.S.A. Inc. 04/2016 Unknown 730 OSENI Tablets 12.5 mg/30 mg Takeda U.S.A. Inc. 04/2016 Unknown 731 OSENI Tablets 12.5 mg/45 mg Takeda U.S.A. Inc. 04/2016 Unknown 732 OVIDE Lotion 0.5% Taro Pharmaceuticals
USA, Inc. 08/02/2008 - 08/01/2009 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 733 OXANDRIN Tablets 2.5 mg Savient
Pharmaceuticals, Inc. 06/2006 - 05/2007 Unknown
734 OXANDRIN Tablets 10 mg Savient Pharmaceuticals, Inc.
06/2006 - 05/2007 Unknown
735 OXSORALEN ULTRA
Capsule 10 mg Dow Pharmaceutical Sciences
07/15/2014 Unknown
736 OXYCODONE HYDROCHLORIDE
Capsules 5 mg Genus Lifesciences, Inc.
12/15/2010 Unknown
737 OXYCODONE HYDROCHLORIDE
Oral Solution 100 mg/5 mL Genus Lifesciences, Inc.
12/20/2010 Unknown
738 OXYCONTIN Extended-release Tablets
15 mg Purdue Pharma 03/2016 Unknown
739 OXYCONTIN Extended-release Tablets
80 mg Purdue Pharma 08/14/2014 Unknown
740 OXYCONTIN Extended-release Tablets
10 mg Purdue Pharma 08/14/2014 Unknown
741 OXYCONTIN Extended-release Tablets
10 mg Purdue Pharma 03/2016 Unknown
742 OXYCONTIN Extended-release Tablets
80 mg Purdue Pharma 03/24/2015 Unknown
743 OXYCONTIN Extended-release Tablets
40 mg Purdue Pharma 03/2016 Unknown
744 OXYCONTIN Extended-release Tablets
20 mg Purdue Pharma 09/29/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 745 OXYCONTIN Extended-
release Tablets 10 mg Purdue Pharma 10/08/2014 Unknown
746 OXYCONTIN Extended-release Tablets
30 mg Purdue Pharma 03/2016 Unknown
747 OXYCONTIN Extended-release Tablets
20 mg Purdue Pharma 03/24/2015 Unknown
748 OXYCONTIN Extended-release Tablets
80 mg Purdue Pharma 09/22/2014 Unknown
749 OXYCONTIN Extended-release Tablets
40 mg Purdue Pharma 08/28/2014 Unknown
750 OXYCONTIN Extended-release Tablets
40 mg Purdue Pharma 09/22/2014 Unknown
751 OXYCONTIN Extended-release Tablets
20 mg Purdue Pharma 03/2016 Unknown
752 OXYCONTIN Extended-release Tablets
60 mg Purdue Pharma 03/2016 Unknown
753 OXYCONTIN Extended-release Tablets
40 mg Purdue Pharma 09/22/2014 Unknown
754 OXYCONTIN Extended-release Tablets
10 mg Purdue Pharma 03/24/2015 Unknown
755 OXYCONTIN Extended-release Tablets
40 mg Purdue Pharma 08/14/2014 Unknown
756 OXYCONTIN Extended-release Tablets
20 mg Purdue Pharma 08/28/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 757 OXYCONTIN Extended-
release Tablets 80 mg Purdue Pharma 09/22/2014 Unknown
758 OXYCONTIN Extended-release Tablets
80 mg Purdue Pharma 08/14/2014 Unknown
759 OXYCONTIN Extended-release Tablets
40 mg Purdue Pharma 03/24/2015 Unknown
760 OXYCONTIN Extended-release Tablets
80 mg Purdue Pharma 03/2016 Unknown
761 PARAPLATIN for Injection 50 mg/vial Bristol-Myers Squibb Company
03/2004 - 02/2005 Unknown
762 PARAPLATIN for Injection 150 mg/vial Bristol-Myers Squibb Company
03/2004 - 02/2005 Unknown
763 PARAPLATIN for Injection 450 mg/vial Bristol-Myers Squibb Company
03/2004 - 02/2005 Unknown
764 PARAPLATIN AQ Injection eq. 50 mg/5 mL (10 mg/mL)
Bristol-Myers Squibb Company
07/2004 - 06/2005 Unknown
765 PARAPLATIN AQ Injection eq. 150 mg/15 mL (10 mg/mL)
Bristol-Myers Squibb Company
07/2004 - 06/2005 Unknown
766 PARAPLATIN AQ Injection eq. 450 mg/45 mL (10 mg/mL)
Bristol-Myers Squibb Company
07/2004 - 06/2005 Unknown
767 PARAPLATIN AQ Injection eq. 600 mg/60 mL (10 mg/mL)
Bristol-Myers Squibb Company
07/2004 - 06/2005 Unknown
768 PARLODEL Capsules 5 mg Validus Pharmaceuticals LLC
12/1998, 4/2006 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 769 PARLODEL Tablets 2.5 mg Validus
Pharmaceuticals LLC Prior to 1/1/1999 Unknown
770 PARNATE Tablets 10 mg Concordia Pharmaceuticals Inc.
02/05/2016 Unknown
771 PATADAY Ophthalmic Solution
0.2% Novartis Pharmaceuticals Corporation
06/2017 Unknown
772 PATANASE Nasal Spray 665 mcg in 100 mg solution
Novartis Pharmaceuticals Corporation
04/2015 Unknown
773 PATANASE Nasal Spray 665 mcg in 100 mg solution
Novartis Pharmaceuticals Corporation
04/2015 Unknown
774 PATANOL Ophthalmic Solution
0.1% Novartis Pharmaceuticals Corporation
09/15/2015 Unknown
775 PAXIL CR Tablets 12.5 mg GlaxoSmithKline 10/21/2010 Unknown 776 PAXIL CR Tablets 25 mg GlaxoSmithKline 10/21/2010 Unknown 777 PAXIL CR Tablets 37.5 mg GlaxoSmithKline 10/21/2010 Unknown 778 PEDIAPRED Oral Solution eq. 5 mg base/5 mL UCB, Inc. 11 Feb 2002 Unknown 779 PHOSLO Gelcaps 667 mg Fresenius Medical
Care North America 03/2014 - 03/2015 Unknown
780 PLAN B ONE STEP Tablets 1.5 mg Teva Branded Pharmaceutical Products R&D, Inc.
02/12/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 781 PLAQUENIL Tablets 200 mg Concordia
Pharmaceuticals Inc. 05/1999 - 04/2000 Unknown
782 PLENDIL Extended-release Tablets
2.5 mg AstraZeneca LP 10/2008 Unknown
783 PLENDIL Extended-release Tablets
5 mg AstraZeneca LP 10/2008 Unknown
784 PLENDIL Extended-release Tablets
10 mg AstraZeneca LP 10/2008 Unknown
785 PLETAL Tablets 50 mg Otsuka Pharmaceutical Company, Ltd.
10/18/2004 Unknown
786 PLETAL Tablets 100 mg Otsuka Pharmaceutical Company, Ltd.
10/18/2004 Unknown
787 POLYTRIM Ophthalmic Solution
10 mL unit Allergan, Inc. 04/29/1997 Unknown
788 PONSTEL Capsules 250 mg Shionogi, Inc. 07/11/2011 Unknown 789 POTASSIUM
CHLORIDE FOR ORAL SOLUTION
Powder for Solution
20 mEq Pharma Research Software Solution, LLC
01/2017 Unknown
790 POTASSIUM CHLORIDE FOR ORAL SOLUTION
Powder for Solution
20 mEq Pharma Research Software Solution, LLC
09/2015 Unknown
791 POTASSIUM CHLORIDE ORAL
Oral Solution 20 mEq per 15 mL Lehigh Valley Technologies
05/14/2015 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing SOLUTION, USP, 10%
792 POTASSIUM CHLORIDE ORAL SOLUTION, USP, 10%
Oral Solution 20 mEq per 15 mL Lehigh Valley Technologies
05/14/2015 Unknown
793 POTASSIUM CHLORIDE ORAL SOLUTION, USP, 20%
Oral Solution 40 mEq per 15 mL Lehigh Valley Technologies
05/14/2015 Unknown
794 PRAVACHOL Tablets 10 mg Bristol-Myers Squibb Company
10/2005 - 09/2006 Unknown
795 PRAVACHOL Tablets 20 mg Bristol-Myers Squibb Company
10/2005 - 09/2006 Unknown
796 PRAVACHOL Tablets 40 mg Bristol-Myers Squibb Company
10/2005 - 09/2006 Unknown
797 PRAVACHOL Tablets 80 mg Bristol-Myers Squibb Company
10/2005 - 09/2006 Unknown
798 PRECOSE Tablets 50 mg Bayer Healthcare Pharmaceuticals, Inc.
01/30/2009 Unknown
799 PRECOSE Tablets 100 mg Bayer Healthcare Pharmaceuticals, Inc.
01/30/2009 Unknown
800 PRECOSE Tablets 25 mg Bayer Healthcare Pharmaceuticals, Inc.
01/30/2008 Unknown
801 PRED FORTE Ophthalmic Suspension
1% Allergan, Inc. 08/1997 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 802 PREVACID Delayed-
Release Capsules
15 mg Takeda Global Research & Development Center, Inc.
11/2009 Unknown
803 PREVACID Delayed-Release Capsules
30 mg Takeda Global Research & Development Center, Inc.
11/2009 Unknown
804 PREVPAC Delayed-Release Capsules, Capsules, and Tablets
30 mg, 500 mg, and 500 mg
Takeda Pharmaceuticals U.S.A., Inc.
03/02/2015 Unknown
805 PRILOSEC Delayed-release Capsules
40 mg AstraZeneca LP 04/2008 Unknown
806 PROCARDIA Capsules 10 mg Pfizer Inc. 3/25/2013 Unknown 807 PROCARDIA XL Extended-
release Tablets 30 mg Pfizer Inc. 3/31/10 and 4/29/10 Unknown
808 PROCARDIA XL Extended-release Tablets
60 mg Pfizer Inc. 3/31/10 and 4/29/10 Unknown
809 PROCARDIA XL Extended-release Tablets
90 mg Pfizer Inc. 3/31/10 and 4/29/10 Unknown
810 PROMETRIUM Capsules 200 mg Virtus Pharmaceuticals,
07/2016 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing LLC
811 PROMETRIUM Capsules 100 mg Virtus Pharmaceuticals, LLC
07/2016 Unknown
812 PROMETRIUM Capsules 200 mg Virtus Pharmaceuticals, LLC
07/30/2010 Unknown
813 PROMETRIUM Capsules 100 mg Virtus Pharmaceuticals, LLC
07/30/2010 Unknown
814 PROVERA Tablets 10 mg Pharmacia and Upjohn
6/18/2003 Unknown
815 PROVERA Tablets 2.5 mg Pharmacia and Upjohn
6/18/2003 Unknown
816 PROVERA Tablets 5 mg Pharmacia and Upjohn
6/18/2003 Unknown
817 PROVIGIL Tablets 100 mg Cephalon, Inc. 03/29/2012 Unknown 818 PROVIGIL Tablets 200 mg Cephalon Inc. 03/29/2012 Unknown 819 PURINETHOL Tablets 50 mg Stason
Pharmaceuticals Inc. 11/2016 Unknown
820 QUALAQUIN Capsules 324 mg Sun Pharmaceutical Industries, Inc.
07/23/2012 Unknown
821 QUEDEXY XR Extended-release Capsules
50 mg Upsher-Smith Pharmaceuticals
07/07/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 822 QUEDEXY XR Extended-
release Capsules
25 mg Upsher-Smith Pharmaceuticals
07/07/2014 Unknown
823 QUEDEXY XR Extended-release Capsules
200 mg Upsher-Smith Pharmaceuticals
07/07/2014 Unknown
824 QUEDEXY XR Extended-release Capsules
100 mg Upsher-Smith Pharmaceuticals
07/07/2014 Unknown
825 QUEDEXY XR Extended-release Capsules
150 mg Upsher-Smith Pharmaceuticals
07/07/2014 Unknown
826 RAPAMUNE Tablets 1 mg PF Prism CV 10/27/2014 Unknown 827 RAPAMUNE Tablets 2 mg PF Prism CV 10/27/2014 Unknown 828 RAPAMUNE Tablets 0.5 mg PF Prism C.V. 01/16/2014 Unknown 829 RAZADYNE Tablets 4 mg Janssen Research and
Development, LLC 08/28/2008 Unknown
830 RAZADYNE Tablets 8 mg Janssen Research and Development, LLC
08/28/2008 Unknown
831 RAZADYNE Tablets 12 mg Janssen Research and Development, LLC
08/28/2008 Unknown
832 RAZADYNE ER Capsules 8 mg Janssen Research and Development, LLC
10/13/2008 Unknown
833 RAZADYNE ER Capsules 16 mg Janssen Research and Development, LLC
10/13/2008 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 834 RAZADYNE ER Capsules 24 mg Janssen Research and
Development, LLC 10/13/2008 Unknown
835 REGLAN Injection eq. 5 mg base/mL Baxter Healthcare Corporation
02/2003 - 02/2004 Unknown
836 REGLAN Tablets eq. 5 mg base A.H. Robins, Inc. 08 March 2010 Unknown 837 RELPAX Tablets 40 mg Pfizer Ireland
Pharmaceuticals 07/2017 Unknown
838 RELPAX Tablets 20 mg Pfizer Ireland Pharmaceuticals
07/2017 Unknown
839 REMERON SOLTAB Orally Disintegrating Tablets
15 mg Organon USA, Inc. 10/06/2004 Unknown
840 REMERON SOLTAB Orally Disintegrating Tablets
30 mg Organon USA, Inc. 10/06/2004 Unknown
841 REMERON SOLTAB Orally Disintegrating Tablets
45 mg Organon USA, Inc. 10/06/2004 Unknown
842 RENVELA Tablets 800 mg Genzyme Corporation
04/16/2014 Unknown
843 RESTORIL Capsules 22.5 mg Mallinckrodt Inc. 07/21/2008 Unknown 844 RESTORIL Capsules 7.5 mg Mallinckrodt Inc. 07/22/2008 Unknown 845 RETIN-A Cream 0.025% Valeant
Pharmaceuticals North America, LLC
09/2014 - 09/2015 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 846 RETIN-A Cream 0.05% Valeant
Pharmaceuticals North America, LLC
02/06/2014 Unknown
847 RETIN-A Cream 0.025% Valeant Pharmaceuticals North America, LLC
09/2014 - 09/2015 Unknown
848 RETIN-A Cream 0.1 % Valeant Pharmaceuticals North America, LLC
01/26/1973 Unknown
849 RETIN-A Cream 0.05% Valeant Pharmaceuticals North America, LLC
07/19/1974 Unknown
850 RETIN-A Cream 0.1% Valeant Pharmaceuticals North America, LLC
02/06/2014 Unknown
851 RETIN-A Cream 0.05% Valeant Pharmaceuticals North America, LLC Valeant Pharmaceuticals North America, LLC Valeant Pharmaceuticals North America, LLC
06/2005 Unknown
852 RETIN-A Gel 0.01 % Valeant Pharmaceuticals
02/06/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing North America, LLC
853 RETIN-A Gel 0.025% Valeant Pharmaceuticals North America, LLC
02/06/2014 Unknown
854 RETIN-A Gel 0.025% Valeant Pharmaceuticals North America, LLC
06/2005 Unknown
855 RETIN-A MICRO Gel 0.04% Valeant Pharmaceuticals North America, LLC
03/2013 Unknown
856 RETIN-A MICRO Gel 0.04% Valeant Pharmaceuticals North America, LLC
10/01/2014 Unknown
857 RETIN-A MICRO Gel 0.1% Valeant Pharmaceuticals North America, LLC
10/01/2014 Unknown
858 RETIN-A MICRO Gel 0.1 % Valeant Pharmaceuticals North America, LLC
03/2013 Unknown
859 REVATIO Tablets 20 mg Pfizer 11/6/2012 Unknown 860 RILUTEK Tablets 50 mg Covis Pharma B.V. 05/15/2013 Unknown 861 RISPERDAL Oral Solution 1 mg/mL Janssen Research &
Development, LLC 06/30/2008 Unknown
862 RISPERDAL Tablets 0.25 mg Janssen Research & Development, LLC
06/30/2008 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 863 RISPERDAL Tablets 0.5 mg Janssen Research &
Development, LLC 06/30/2008 Unknown
864 RISPERDAL Tablets 1 mg Janssen Research & Development, LLC
06/30/2008 Unknown
865 RISPERDAL Tablets 2 mg Janssen Research & Development, LLC
06/30/2008 Unknown
866 RISPERDAL Tablets 3 mg Janssen Research & Development, LLC
06/30/2008 Unknown
867 RISPERDAL Tablets 4 mg Janssen Research & Development, LLC
06/30/2008 Unknown
868 RISPERDAL M-TAB Orally Disintegrating Tablets
0.5 mg Janssen Research & Development, LLC
06/30/2008 Unknown
869 RISPERDAL M-TAB Orally Disintegrating Tablets
1 mg Janssen Research & Development, LLC
02/24/2009 Unknown
870 RISPERDAL M-TAB Orally Disintegrating Tablets
2 mg Janssen Research & Development, LLC
02/24/2009 Unknown
871 RISPERDAL M-TAB Orally Disintegrating Tablets
3 mg Janssen Research & Development, LLC
02/24/2009 Unknown
872 RISPERDAL M-TAB Orally Disintegrating Tablets
4 mg Janssen Research & Development, LLC
02/24/2009 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 873 RITALIN Tablet 10 mg Novartis
Pharmaceuticals Corp 6/8/2007 Unknown
874 RITALIN Tablet 5 mg Novartis Pharmaceuticals Corp
10/09/2007 Unknown
875 RITALIN Tablet 20 mg Novartis Pharamceuticals Corp
8/23/2007 Unknown
876 RITALIN SR Extended-release Tablets
20 mg Novartis Pharmaceuticals Corporation
03/09/2007 Unknown
877 ROBINUL Injection 0.2 mg/mL Eurohealth International Sarl
02/06/1975 Unknown
878 ROBINUL Tablets 1 mg Shionogi Pharma, Inc.
01/13/2005 Unknown
879 ROBINUL FORTE Tablets 2 mg Shionogi Pharma, Inc.
01/13/2005 Unknown
880 ROCALTROL Capsules 0.25 mcg Validus Pharmaceuticals LLC
08/26/2009 Unknown
881 ROCALTROL Capsules 0.5 mcg Validus Pharmaceuticals LLC
08/26/2009 Unknown
882 ROCALTROL Oral Solution 1 mcg/mL (15 mL bottle) Validus Pharmaceuticals LLC
08/26/2009 Unknown
883 ROGAINE (FOR MEN)
Topical Solution
2% McNeil-PPC, Inc. 06/1998 - 05/1999 Unknown
884 ROGAINE (FOR WOMEN)
Topical Solution
2% McNeil-PPC, Inc. 06/1998 - 05/1999 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 885 ROGAINE EXTRA
STRENGTH (FOR MEN)
Topical Solution
5% McNeil-PPC, Inc. 2004 Unknown
886 ROWASA Rectal Enema 4 gm/60 mL Meda Pharmaceutical Inc.
2/2011 Unknown
887 ROWASA Rectal Enema 4 gm/60 mL Meda Pharmaceuticals Inc.
2009 Unknown
888 RYTHMOL SR Extended-release Capsules
425 mg GlaxoSmithKline LLC
Unknown Unknown
889 RYTHMOL SR Extended-release Capsules
225 mg GlaxoSmithKline LLC
10/22/2013 Unknown
890 RYTHMOL SR Extended-release Capsules
325 mg GlaxoSmithKline LLC
10/22/2014 Unknown
891 SALAGEN Tablets 5 mg MGI Pharma, Inc. 12/2004 Unknown 892 SALAGEN Tablets 7.5 mg MGI Pharma, Inc. 03/2006 - 01/2007 Unknown 893 SANDOSTATIN Injection eq. 0.05 mg base/mL Novartis
Pharmaceuticals Corporation
04/13/2005 Unknown
894 SANDOSTATIN Injection eq. 0.1 mg base/mL Novartis Pharmaceuticals Corporation
04/13/2005 Unknown
895 SANDOSTATIN Injection eq. 0.2 mg base/mL Novartis 04/13/2005 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Pharmaceuticals Corporation
896 SANDOSTATIN Injection eq. 0.5 mg base/mL Novartis Pharmaceuticals Corporation
04/13/2005 Unknown
897 SANDOSTATIN Injection eq. 1 mg base/mL Novartis Pharmaceuticals Corporation
04/13/2005 Unknown
898 SEASONALE Tablets 0.15 mg; 0.03 mg Duramed Pharmaceuticals, Inc.
9/7/2006 Unknown
899 SEASONIQUE Tablets 0.15 mg/0.03 mg and 0.01 mg
Teva Branded Pharmaceutical Products
07/28/2010 Unknown
900 SECTRAL Capsules eq. 200 mg base Wyeth Laboratories, Inc.
Prior to 1/1/1999 Unknown
901 SECTRAL Capsules eq. 400 mg base Wyeth Laboratories, Inc.
Prior to 1/1/1999 Unknown
902 SEPTOCAINE Injection 4% and 1:200,000 Deproco, Inc. 01/2015 Unknown 903 SEPTOCAINE Injection 4% and 1:100,000 Deproco, Inc. 01/2015 Unknown 904 SILVADENE Cream 1% King Pharmaceuticals,
Inc. Prior to 1/1/1999 Unknown
905 SINEMET Tablets 10 mg; 100 mg Bristol-Myers Squibb Company
05/2001 - 05/2002 Unknown
906 SINEMET Tablets 25 mg; 250 mg Bristol-Myers Squibb Company
05/2001 - 05/2002 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 907 SINEMET Tablets 25 mg; 100 mg Bristol-Myers Squibb
Company 05/2001 - 05/2002 Unknown
908 SINGULAIR Oral Granules 4 mg Merck Sharp & Dohme Corp
8/7/2013 Unknown
909 SKELAXIN Tablets 800 mg King Pharmaceuticals, LLC
04/01/2010 Unknown
910 SODIUM EDECRIN Powder, for Solution
50 mg/vial (single dose vial for preparation of IV solution)
Aton Pharma, Inc. 01/2015 - 01/2016 Unknown
911 SOLARAZE Gel 3% Fougera Pharmaceuticals, Inc.
11/21/2013 Unknown
912 SOMA Tablet 250 mg Meda Pharmaceuticals
9/13/2010 Unknown
913 SORIATANE Capsules 10 mg Stiefel Laboratories Inc.
7/22/2013 Unknown
914 SORIATANE Capsules 25 mg Stiefel Laboratories Inc.
7/22/2013 Unknown
915 SPECTRACEF Tablets 200 mg Vansen Pharma, Inc. Unknown Unknown 916 SPECTRACEF Tablets 400 mg Vansen Pharma, Inc. Unknown Unknown 917 SPORANOX Capsule 100 mg Janssen Research &
Development, LLC 2/2005; 6/2005 Unknown
918 STALEVO 100 Film-coated Tablets
25 mg, 100 mg, 200 mg Orion Pharma 06/2014 Unknown
919 STALEVO 100 Film-coated 25 mg, 100 mg, 200 mg Orion Pharma 10/2012 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Tablets
920 STALEVO 125 Film-coated Tablets
31.25 mg, 125 mg, 200 mg
Orion Pharma 4/2012 Unknown
921 STALEVO 125 Film-coated Tablets
31.25 mg, 125 mg, 200 mg
Orion Pharma 06/2014 Unknown
922 STALEVO 150 Film-coated Tablets
37.5mg, 150 mg, 200 mg Orion Pharma 06/2014 Unknown
923 STALEVO 150 Film-coated Tablets
37.5 mg, 150 mg, 200 mg Orion Pharma 10/2012 Unknown
924 STALEVO 200 Film-coated Tablets
50 mg, 200 mg, 200 mg Orion Pharma 4/2012 Unknown
925 STALEVO 200 Film-coated Tablets
50 mg, 200 mg, 200 mg Orion Pharma 06/2014 Unknown
926 STALEVO 50 Film-coated Tablets
12.5 mg, 50 mg, 200 mg Orion Pharma 06/2014 Unknown
927 STALEVO 50 Film-coated Tablets
12.5 mg, 50 mg, 200 mg Orion Pharma 4/2012 Unknown
928 STALEVO 75 Film-coated Tablets
18.75 mg, 75 mg, 200 mg Orion Pharma 10/2013 Unknown
929 STALEVO 75 Film-coated Tablets
18.75 mg, 75 mg, 200 mg Orion Pharma 4/2012 Unknown
930 STALEVO 75 Film-coated Tablets
18.75 mg, 75 mg, 200 mg Orion Pharma 06/2014 Unknown
931 STELEVO 100 Film-coated 25 mg, 100 mg, 200 mg Orion Pharma 10/2013 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Tablets
932 STELEVO 125 Film-coated Tablets
31.25 mg, 125 mg, 200 mg
Orion Pharma 10/2013 Unknown
933 STELEVO 150 Film-coated Tablets
37.5 mg, 150 mg, 200 mg Orion Pharma 10/2013 Unknown
934 STELEVO 200 Film-coated Tablets
50 mg, 200 mg, 200 mg Orion Pharma 10/2013 Unknown
935 STRATTERA Capsules 100 mg Eli Lilly and Company
05/2017 Unknown
936 STRATTERA Capsules 80 mg Eli Lilly and Company
05/2017 Unknown
937 STRATTERA Capsules 60 mg Eli Lilly and Company
05/2017 Unknown
938 STRATTERA Capsules 40 mg Eli Lilly and Company
05/2017 Unknown
939 STRATTERA Capsules 25 mg Eli Lilly and Company
05/2017 Unknown
940 STRATTERA Capsules 18 mg Eli Lilly and Company
05/2017 Unknown
941 STRATTERA Capsules 10 mg Eli Lilly and Company
05/2017 Unknown
942 SULAR Extended-release Tablets
17 mg Shionogi Inc. 2/2012 - 2/2013 Unknown
943 SULAR Extended- 8.5 mg Shionogi Inc. 2/2012 - 2/2013 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing release Tablets
944 SULAR Extended-release Tablets
34 mg Shionogi Inc. 2/2012 - 2/2013 Unknown
945 SYNALAR Cream 0.025% Medimetriks Pharmaceuticals, Inc.
12/2012 Unknown
946 SYNALAR Cream 0.01% Medimetriks Pharmaceuticals, Inc.
Unknown Unknown
947 SYNALAR Ointment 0.025% Medimetriks Pharmaceuticals, Inc.
12/2012 Unknown
948 SYNALAR Solution 0.01% Medimetriks Pharmaceuticals, Inc.
11/2012 Unknown
949 SYNALGOS-DC Capsules 356.4 mg/30 mg/16 mg Sun Pharmaceutical Industries, Inc.
10/01/2012 Unknown
950 TACLONEX Ointment 0.005%/0.064% LEO Pharma A/S 04/2014 Unknown 951 TAMBOCOR Tablets 50 mg 3M Pharmaceuticals 10/2002 Unknown 952 TAMBOCOR Tablets 100 mg 3M Pharmaceuticals 10/2002 Unknown 953 TAMBOCOR Tablets 150 mg 3M Pharmaceuticals 10/2002 Unknown 954 TARGRETIN Capsules 75 mg Valeant
Pharmaceuticals North America, LLC
12/2015 Unknown
955 TARKA Extended-release Tablets
1 mg Trandolapril, 240 mg Verapamil Hydrochloride
AbbVie 02/25/2015 Unknown
956 TARKA Extended-release Tablets
2 mg Trandolapril, 180 mg Verapamil Hydrochloride
AbbVie 02/25/2015 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 957 TARKA Extended-
release Tablets 4 mg Trandolapril, 240 mg Verapamil Hydrochloride
AbbVie 02/25/2015 Unknown
958 TARKA Extended-release Tablets
2 mg Trandolapril, 240 mg Verapamil Hydrochloride
AbbVie 02/25/2015 Unknown
959 TASMAR Tablets 100 mg Valeant Pharmaceuticals North America, LLC
07/2004 Unknown
960 TAXOTERE Injection Concentrate
20 mg/mL Sanofi Aventis US LLC
03/2011 Unknown
961 TAXOTERE Injection Concentrate
80 mg/4 mL Sanofi Aventis US LLC
03/2011 Unknown
962 TAZORAC Cream 0.05% Allergan 10/2016 Unknown 963 TAZORAC and
AVAGE Cream 0.1% Allergan 10/2016 Unknown
964 TEGRETOL XR Tablets 100 mg Novartis Pharmaceuticals Corporation
03/2016 Unknown
965 TEGRETOL XR Tablets 200 mg Novartis Pharmaceuticals Corporation
06/15/2009 Unknown
966 TEGRETOL XR Tablets 400 mg Novartis Pharmaceuticals Corporation
06/15/2009 Unknown
967 TEMODAR Capsules 20 mg Merck Sharp & Dohme Corporation
8/12/2013 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 968 TEMODAR Capsules 250 mg Merck Sharp &
Dohme Corporation 8/12/2013 Unknown
969 TEMODAR Capsules 180 mg Merck Sharp & Dohme Corporation
8/12/2013 Unknown
970 TEMODAR Capsules 140 mg Merck Sharp & Dohme Corporation
8/12/2013 Unknown
971 TEMODAR Capsules 100 mg Merck Sharp & Dohme Corporation
8/12/2013 Unknown
972 TEMODAR Capsules 5 mg Merck Sharp & Dohme Corporation
8/12/2013 Unknown
973 TENUATE Immediate-release Tablets
25 mg Actavis Laboratories UT Inc.
12/20/1996 Unknown
974 TENUATE DOSPAN Controlled-release Tablets
75 mg Actavis Laboratories UT, Inc.
07/24/1994 Unknown
975 TESSALON Capsules 100 mg Forest Laboratories, Inc.
Prior to 1/1/1999 Unknown
976 TESSALON Capsules 200 mg Forest Laboratories, Inc.
04/1999 - 04/2000 Unknown
977 TESTIM Gel 50 mg in 5 g Auxilium Pharmaceuticals, Inc.
06/09/2014 Unknown
978 TIAZAC Extended-release Capsules
120 mg Valeant Pharmaceuticals North America, LLC
08/20/2014 Unknown
979 TIAZAC Extended-release
180 mg Valeant Pharmaceuticals
08/20/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Capsules North America, LLC
980 TIAZAC Extended-release Capsules
240 mg Valeant Pharmaceuticals North America, LLC
08/20/2014 Unknown
981 TIAZAC Extended-release Capsules
300 mg Valeant Pharmaceuticals North America, LLC
08/20/2014 Unknown
982 TIAZAC Extended-release Capsules
420 mg Valeant Pharmaceuticals North America, LLC
08/20/2014 Unknown
983 TIAZAC Extended-release Capsules
360 mg Valeant Pharmaceuticals North America, LLC
08/20/2014 Unknown
984 TIGAN Injection 100 mg/mL Par Sterile Products, LLC
06/01/2012 Unknown
985 TIKOSYN Capsules 0.125 mg Pfizer 05/01/2016 Unknown 986 TIKOSYN Capsules 0.25 mg Pfizer 05/01/2016 Unknown 987 TIKOSYN Capsules 0.5 mg Pfizer 05/01/2016 Unknown 988 TIMOPTIC-XE Solution 0.5% Aton Pharma, a
division of VPNA LLC
11/1993 Unknown
989 TINDAMAX Tablets 250 mg Mission Pharmacal Company
06/07/2012 Unknown
990 TINDAMAX Tablets 500 mg Mission Pharmacal Company
06/07/2012 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 991 TOBI Solution for
Inhalation 300 mg/5 mL ampule Novartis
Pharmaceuticals Corporation
07/2014 Unknown
992 TOBRADEX Opthalmic Suspension
0.3%, 0.1% Novartis Pharmaceuticals Corporation
01/02/2009 Unknown
993 TOFRONIL PM Capsules 100 mg Mallinckrodt Inc. 4/2006 Unknown 994 TOFRONIL PM Capsules 150 mg Mallinckrodt Inc. 4/2006 Unknown 995 TOFRONIL PM Capsules 125 mg Mallinckrodt Inc. 4/2006 Unknown 996 TOFRONIL PM Capsules 75 mg Mallinckrodt Inc. 4/2006 Unknown 997 TOPROL XL Extended-
release Tablets 25 mg Aralez
Pharmaceuticals Trading DAC
01/2018 Unknown
998 TOPROL XL Extended-release Tablets
50 mg Aralez Pharmaceuticals Trading DAC
01/2018 Unknown
999 TOPROL XL Extended-release Tablets
100 mg Aralez Pharmaceuticals Trading DAC
01/2018 Unknown
1000 TOPROL XL Extended-release Tablets
200 mg Aralez Pharmaceuticals Trading DAC
01/2018 Unknown
1001 TORADOL Tablets 10 mg Syntex (U.S.A.) Inc. Prior to 1/1/1999 Unknown 1002 TRANDATE Tablets 300 mg County Line
Pharmaceuticals, 12/01/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing LLC
1003 TRANDATE Tablets 200 mg County Line Pharmaceuticals, LLC
12/01/2014 Unknown
1004 TRANDATE Tablets 100 mg County Line Pharmaceuticals, LLC
12/01/2014 Unknown
1005 TRICOR Tablets 48 mg AbbVie Inc. 04/2014 Unknown 1006 TRICOR Tablets 145 mg AbbVie Inc. 04/2014 Unknown 1007 TRILEPTAL Oral
Suspension 300 mg/5 mL Novartis
Pharmaceuticals Corporation
01/04/2011 Unknown
1008 TRILIPIX Delayed Release Capsules
45 mg AbbVie Inc. 07/15/2013 Unknown
1009 TRILIPIX Delayed Release Capsules
135 mg AbbVie Inc. 07/15/2013 Unknown
1010 TRILIPIX Delayed Release Capsules
135 mg AbbVie Inc. 07/15/2013 Unknown
1011 TRILIPIX Delayed Release Capsules
45 mg AbbVie Inc. 07/15/2013 Unknown
1012 TRI-NORINYL Tablets 0.5 mg, 1 mg, 0.5 mg; Mayne Pharma LLC 08/2016 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 0.035 mg, 0.035 mg, 0.035 mg
1013 TRI-NORINYL Tablets 0.5 mg, 1 mg, 0.5 mg; 0.035 mg, 0.035 mg, 0.035 mg
Mayne Pharma LLC 1/12/2005 Unknown
1014 TUSSIONEX Extended-Release Suspension
10 mg hydrocodone bitartrate & 8 mg chlorpheniramine maleate per 5 mL
UCB, Inc. 10/2010 Unknown
1015 ULTRAM Extended-release Tablets
100 mg Valeant Pharmaceuticals North America LLC
01/16/2006 Unknown
1016 ULTRAM Extended-release Tablets
300 mg Valeant Pharmaceuticals North America LLC
01/16/2006 Unknown
1017 ULTRAM Extended-release Tablets
200 mg Valeant Pharmaceuticals North America LLC
01/16/2006 Unknown
1018 ULTRAVATE Cream 0.05% Bristol-Myers Squibb Company
11/2004 - 10/2005 Unknown
1019 ULTRAVATE Ointment 0.05% Bristol-Myers Squibb Company
11/2004 - 10/2005 Unknown
1020 UNITHROID Tablets 0.025 mg Jerome Stevens Pharmaceuticals, Inc.
08/2002 - 07/2003 Unknown
1021 UNITHROID Tablets 0.05 mg Jerome Stevens 08/2002 - 07/2003 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Pharmaceuticals, Inc.
1022 UNITHROID Tablets 0.075 mg Jerome Stevens Pharmaceuticals, Inc.
08/2002 - 07/2003 Unknown
1023 UNITHROID Tablets 0.088 mg Jerome Stevens Pharmaceuticals, Inc.
08/2002 - 07/2003 Unknown
1024 UNITHROID Tablets 0.1 mg Jerome Stevens Pharmaceuticals, Inc.
08/2002 - 07/2003 Unknown
1025 UNITHROID Tablets 0.112 mg Jerome Stevens Pharmaceuticals, Inc.
08/2002 - 07/2003 Unknown
1026 UNITHROID Tablets 0.125 mg Jerome Stevens Pharmaceuticals, Inc.
08/2002 - 07/2003 Unknown
1027 UNITHROID Tablets 0.15 mg Jerome Stevens Pharmaceuticals, Inc.
08/2002 - 07/2003 Unknown
1028 UNITHROID Tablets 0.175 mg Jerome Stevens Pharmaceuticals, Inc.
08/2002 - 07/2003 Unknown
1029 UNITHROID Tablets 0.2 mg Jerome Stevens Pharmaceuticals, Inc.
08/2002 - 07/2003 Unknown
1030 UNITHROID Tablets 0.3 mg Jerome Stevens Pharmaceuticals, Inc.
08/2002 - 07/2003 Unknown
1031 UREX Tablets 1 gram County Line Pharmaceuticals, LLC
Unknown Unknown
1032 UROCIT-K Extended-release Tablets
15 mEQ (1620 mg) per tablet
Mission Pharmacal 12/23/2013 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 1033 UROCIT-K Extended-
release Tablets 540 mg (5 mEq per tablet) Mission Pharmacal 11/2007 Unknown
1034 UROCIT-K Extended-release Tablets
1080 mg (10 mEq per tablet)
Mission Pharmacal 11/2007 Unknown
1035 URSO 250 Tablets 250 mg Allergan Sales, LLC 07/06/2009 Unknown 1036 URSO FORTE Tablets 500 mg Allergan Sales, LLC 07/06/2009 Unknown 1037 VAGISTAT-1 Vaginal
Ointment 6.50% Bristol-Myers Squibb
Company 02/1998 - 02/1999 Unknown
1038 VANCOCIN Capsules 250 mg ANI Pharmaceuticals Inc.
10/26/2015 Unknown
1039 VANCOCIN Capsules 125 mg ANI Pharmaceuticals Inc.
10/26/2015 Unknown
1040 VANOS Cream 0.1% Medicis Pharmaceutical Corporation
01/2014 Unknown
1041 VASERETIC Tablets 10 mg/25 mg Valeant Pharmaceuticals North America, LLC
10/31/1986 Unknown
1042 VASOTEC Tablets 5 mg Valeant Pharmaceuticals North America, LLC
12/24/1985 Unknown
1043 VASOTEC Tablets 10 mg Valeant Pharmaceuticals North America, LLC
12/24/1985 Unknown
1044 VASOTEC Tablets 2.5 mg Valeant 07/26/1988 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Pharmaceuticals North America, LLC
1045 VASOTEC Tablets 20 mg Valeant Pharmaceuticals North America, LLC
12/24/1985 Unknown
1046 VECTICAL Ointment 3 mcg/g Galderma Laboratories, L.P.
02/28/2012 Unknown
1047 VENLAFAXINE HYDROCHLORIDE EXTENDED RELEASE TABLETS
Tablet, Extended Release
150 mg Osmotica Pharmaceutical US LLC
04/2010 Unknown
1048 VENLAFAXINE HYDROCHLORIDE EXTENDED RELEASE TABLETS
Tablet, Extended Release
225 mg Osmotica Pharmaceutical US LLC
04/2010 Unknown
1049 VENLAFAXINE HYDROCHLORIDE EXTENDED RELEASE TABLETS
Tablet, Extended Release
37.5 mg Osmotica Pharmaceutical US LLC
04/2010 Unknown
1050 VENLAFAXINE HYDROCHLORIDE EXTENDED RELEASE TABLETS
Tablet, Extended Release
75 mg Osmotica Pharmaceutical US LLC
04/2010 Unknown
1051 VENLAFAXINE HYDROCHLORIDE EXTENDED RELEASE TABLETS
Tablet, Extended Release
37.5 mg Osmotica Pharmaceutical US LLC
04/2010 Unknown
1052 VENLAFAXINE HYDROCHLORIDE
Tablet, Extended
75 mg Osmotica Pharmaceutical US
04/2010 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing EXTENDED RELEASE TABLETS
Release LLC
1053 VENLAFAXINE HYDROCHLORIDE EXTENDED RELEASE TABLETS
Tablet, Extended Release
150 mg Osmotica Pharmaceutical US LLC
04/2010 Unknown
1054 VENLAFAXINE HYDROCHLORIDE EXTENDED RELEASE TABLETS
Tablet, Extended Release
225 mg Osmotica Pharmaceutical US LLC
04/2010 Unknown
1055 VENOFER Injection 2% w/v iron (Fe) Luitpold Pharmaceuticals, Inc.
10/02/08 Unknown
1056 VERELAN Sustained-release Capsules
120 mg Recro Gainesville LLC
5/17/1999 Unknown
1057 VERELAN Sustained-release Capsules
180 mg Recro Gainesville LLC
5/17/1999 Unknown
1058 VERELAN Sustained-release Capsules
240 mg Recro Gainesville LLC
5/17/1999 Unknown
1059 VERELAN Sustained-release Capsules
360 mg Recro Gainesville LLC
5/17/1999 Unknown
1060 VERELAN PM Extended-release Capsules
100 mg Recro Gainesville LLC
11/2006 - 11/2007 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 1061 VERELAN PM Extended-
release Capsules
200 mg Recro Gainesville LLC
11/2006 - 11/2007 Unknown
1062 VERELAN PM Extended-release Capsules
300 mg Recro Gainesville LLC
11/2006 - 11/2007 Unknown
1063 VFEND Powder for Oral Suspension
40 mg/mL (75 mL when reconstituted)
PF Prism C.V. 12/16/2013 Unknown
1064 VFEND Tablets 50 mg PF Prism C.V. 07/08/2010 Unknown 1065 VFEND Tablets 200 mg PF Prism C.V. 07/08/2010 Unknown 1066 VIDAZA Injection,
Powder, Lyophylized, for Solution
100 mg single-use vial Celgene Corporation 09/16/2013 Unknown
1067 VIRAMUNE Oral Suspension
50 mg/5 mL Boehringer-Ingleheim Pharmaceuticals, Inc.
05/21/2012 Unknown
1068 VIRAMUNE Tablets 200 mg Boehringer-Ingleheim Pharmaceuticals, Inc.
05/21/2012 Unknown
1069 VIROPTIC Ophthalmic Solution
1% Monarch Pharmaceuticals, LLC
08/20/2012 Unknown
1070 VIVELLE-DOT Transdermal System
0.1 mg Novartis Pharmaceuticals Corporation
12/2014 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 1071 VIVELLE-DOT Transdermal
System 0.075 mg Novartis
Pharmaceuticals Corporation
12/2014 Unknown
1072 VIVELLE-DOT Transdermal System
0.05 mg Novartis Pharmaceuticals Corporation
12/2014 Unknown
1073 VIVELLE-DOT Transdermal System
0.0375 mg Novartis Pharmaceuticals Corporation
12/2014 Unknown
1074 VIVELLE-DOT Transdermal System
0.025 mg Novartis Pharmaceuticals Corporation
12/2014 Unknown
1075 VOGELXO Gel 50 mg Upsher-Smith Laboratories
06/2014 Unknown
1076 VOLTAREN Delayed-release Tablets
25 mg Novartis Pharmaceuticals Corporation
Prior to 1/1/1999 Unknown
1077 VOLTAREN Delayed-release Tablets
50 mg Novartis Pharmaceuticals Corporation
Prior to 1/1/1999 Unknown
1078 VOLTAREN Gel 1% GlaxoSmithKline Consumer Healthcare
07/2016 Unknown
1079 VOLTAREN XR Extended-release Tablets
100 mg Novartis Pharmaceuticals Corporation
05/22/2000 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 1080 XALATAN Ophthalmic
Solution 0.005% (125 mcg/2.5 mL) Pharmacia and
Upjohn Company 11/15/2010 Unknown
1081 XANAX Tablets 0.25 mg Pharmacia and Upjohn Company
06/17/2003 Unknown
1082 XANAX Tablets 0.5 mg Pharmacia and Upjohn Company
06/18/2003 Unknown
1083 XANAX Tablets 1 mg Pharmacia and Upjohn Company
06/18/2003 Unknown
1084 XANAX Tablets 2 mg Pharmacia and Upjohn Company
06/18/2003 Unknown
1085 XANAX XR Extended-release Tablets
0.5 mg Pharmacia and Upjohn
11/16/2005 Unknown
1086 XANAX XR Extended-release Tablets
1 mg Pharmacia and Upjohn
11/16/2005 Unknown
1087 XANAX XR Extended-release Tablets
2 mg Pharmacia and Upjohn
11/16/2005 Unknown
1088 XANAX XR Extended-release Tablets
3 mg Pharmacia and Upjohn
11/16/2005 Unknown
1089 XENAZINE Tablets 25 mg Valeant Pharmaceuticals North America, LLC
07/20/2015 Unknown
1090 XENAZINE Tablets 12.5 mg Valeant Pharmaceuticals North America, LLC
07/20/2015 Unknown
1091 XOPENEX Inhalation 0.63 mg/3 mL Oak Pharmaceuticals, 08/2012 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing Solution Inc.
1092 XOPENEX Inhalation Solution
0.31 mg/3 mL Oak Pharmaceuticals, Inc.
08/2012 Unknown
1093 XOPENEX Inhalation Solution
1.25 mg/3 mL Oak Pharmaceuticals, Inc.
08/2012 Unknown
1094 YASMIN Tablets 3 mg; 0.03 mg Bayer HealthCare Pharmaceuticals Inc.
05/09/2008 Unknown
1095 ZARONTIN Capsules 250 mg Parke-Davis Division of Pfizer Inc.
10/12/2015 Unknown
1096 ZARONTIN Oral Solution 250 mg/5 mL Parke-Davis Division of Pfizer Inc.
10/12/2015 Unknown
1097 ZAROXOLYN Tablets 2.5 mg UCB, Inc. 11/2002 - 10/2003 Unknown 1098 ZAROXOLYN Tablets 5 mg UCB, Inc. 11/2002 - 10/2003 Unknown 1099 ZAROXOLYN Tablets 10 mg UCB, Inc. 11/2002 - 10/2003 Unknown 1100 ZEBETA Tablets 5 mg Lederle Laboratories 08/2000 - 08/2001 Unknown 1101 ZEBETA Tablets 10 mg Lederle Laboratories 08/2000 - 08/2001 Unknown 1102 ZEGERID Capsules 40 mg Salix Pharmaceuticals,
Inc. 02/27/2006 Unknown
1103 ZEGERID Capsules 20 mg Salix Pharmaceuticals, Inc.
02/27/2006 Unknown
1104 ZEGERID Capsules 40 mg Salix Pharmaceuticals, Inc.
02/27/2006 Unknown
1105 ZEGERID Capsules 20 mg Salix Pharmaceuticals, Inc.
02/27/2006 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 1106 ZEMPLAR Capsules 2 mcg AbbVie Inc. 03/2014 Unknown 1107 ZEMPLAR Capsules 1 mcg AbbVie Inc. 03/2014 Unknown 1108 ZENPEP Delayed
Release Capsules
5000 lipase USP units Eurand Pharmaceuticals, Ltd.
12/2/2009 Unknown
1109 ZIAC Tablets 2.5 mg; 6.25 mg Lederle Laboratories 07/2000 - 07/2001 Unknown 1110 ZIAC Tablets 5 mg; 6.25 mg Lederle Laboratories 07/2000 - 07/2001 Unknown 1111 ZIAC Tablets 10 mg; 6.25 mg Lederle Laboratories 07/2000 - 07/2001 Unknown 1112 ZITHROMAX Powder for
Oral Suspension
100 mg/5 mL (300 mg bottle, 15 mL when mixed)
Pfizer Inc. 02/01/2005 Unknown
1113 ZITHROMAX Powder for Oral Suspension
200 mg/5 mL (600 mg bottle, 15 mL when mixed)
Pfizer Inc. 02/1/2005 Unknown
1114 ZITHROMAX Powder for Oral Suspension
200 mg/5 mL (900 mg bottle, 22.5 mL when mixed)
Pfizer Inc. 02/01/2005 Unknown
1115 ZITHROMAX Powder for Oral Suspension
1 gram (single dose packet)
Pfizer Inc. 2/1/2005 Unknown
1116 ZITHROMAX Powder for Oral Suspension
1200 mg (30 mL when mixed)
Pfizer Inc. 02/01/2005 Unknown
1117 ZITHROMAX Tablets 250 mg Pfizer Inc. 02/01/2005 Unknown
Proprietary Name Dosage Form Strength NDA Applicant Name
Date Authorized Generic
Entered the Market
Date Authorized
Generic Ceased
Marketing 1118 ZITHROMAX Tablets 500 mg Pfizer Inc. 02/01/2005 Unknown 1119 ZITHROMAX Tablets 600 mg Pfizer Inc. 2/1/2005 Unknown 1120 ZOLOFT Oral
Concentrate 20 mg/mL Pfizer Inc. 03/20/2006 Unknown
1121 ZOLOFT Tablets 25 mg Pfizer Inc. 03/20/2006 Unknown 1122 ZOLOFT Tablets 50 mg Pfizer Inc. 03/20/2006 Unknown 1123 ZOLOFT Tablets 100 mg Pfizer Inc. 03/20/2006 Unknown 1124 ZONALON and
PRUDOXIN Cream 5% Mylan
Pharmaceuticals, Inc. 03/2016 Unknown
1125 ZOVIRAX Ointment 5% Valeant Pharmaceuticals North America LLC
04/2014 Unknown
1126 ZOVIRAX Suspension 200 mg per 5 mL Mylan Pharmaceuticals Inc.
09/2014 Unknown
1127 ZUTRIPRO Oral Solution 5 mg/4 mg/60 mg per 5 mL
Cypress Pharmaceutical, Inc.
01/2014 Unknown
1128 ZYFLO Extended-release Tablets
600 mg Chiesi USA, Inc. 04/2017 Unknown
1129 ZYVOX Oral Suspension
100 mg/5 mL Pharmacia and Upjohn Company
12/2015 Unknown
1130 ZYVOX Tablets 600 mg Pharmacia and Upjohn Company
06/2015 Unknown
1131 ZYVOX Tablets 600 mg Pharmacia and Upjohn Company
12/2015 Unknown