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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:206628Orig1s000 MICROBIOLOGY/VIROLOGY REVIEW(S)Product Quality Microbiology Review 27 APR 2015 NDA:206628Drug Product Name Nonproprietary:

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What is drugsfda data files fda?

DrugsFDA Data Files FDA are files containing information about drug products approved by the Food and Drug Administration.

Who is required to file drugsfda data files fda?

Manufacturers or sponsors of drug products approved by the FDA are required to file DrugsFDA Data Files FDA.

How to fill out drugsfda data files fda?

DrugsFDA Data Files FDA can be filled out electronically through the FDA's electronic submission gateway.

What is the purpose of drugsfda data files fda?

The purpose of DrugsFDA Data Files FDA is to provide public access to information about FDA-approved drug products.

What information must be reported on drugsfda data files fda?

Information such as drug names, approval dates, active ingredients, and indications must be reported on DrugsFDA Data Files FDA.

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