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)

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Page 1: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209347Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

Page 3: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

Page 4: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

Page 5: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

Page 6: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

Page 7: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

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Page 8: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

Page 9: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

Page 10: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

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

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Page 14: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

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Reference ID: 4062271

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Page 19: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

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Page 20: 209347Orig1s000 - Food and Drug Administration...mg/ml. ganciclovir in a 250 ml. single-dose bags for intravenous use. Each intravenous bag contains 500 mg of ganciclovn, USP m 0.8%

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