209347orig1s000 - food and drug administration...mg/ml. ganciclovir in a 250 ml. single-dose bags...

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CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209347Orig1s000

PRODUCT QUALITY REVIEW(S)

BalajeeShanmugam

Digitally signed by Balajee Shanmugam

Date: 1/26/2017 02:57:31PM

GUID: 50758d5000003c1b1962e036ea11002c

MiltonSloan

Digitally signed by Milton Sloan

Date: 1/26/2017 12:35:14PM

GUID: 508da72000029fa0e17abc24c6841f0a

StephenMiller

Digitally signed by Stephen Miller

Date: 1/19/2017 06:59:41PM

GUID: 508da7210002a000609476bbecd040f0

Reference ID: 4062271

NealSweeney

Digitally signed by Neal Sweeney

Date: 11/03/2016 11:30 23AM

GUID: 508da70c00028f5119acd77351f33159

BernardMarasa

Digitally signed by Bernard Marasa

Date: 9/27/2016 09:24:48AM

GUID: 54ac2b9800048dc097b4532d3f200cdd

ElsbethChikhale

Digitally signed by Elsbeth Chikhale

Date: 10/13/2016 10:39 25AM

GUID: 50743ccc000031928b54eba1769a5df9

MeiOu

Digitally signed by Mei Ou

Date: 10/13/2016 10:13 30AM

GUID: 54ca9d7000073c57d2eb7cc6e42c05bb

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