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CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for:APPLICATION NUMBER:NDA 021246/S039 Trade Name:TAMIFLUGeneric Name: Phosphate Sponsor:HOFFMAN ROCHE INC. Approval Date: 03/21/2011 Indications:
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What is nda 021246s-039?
It is a specific form required for drug registration with the FDA.
Who is required to file nda 021246s-039?
Any pharmaceutical company seeking FDA approval for a new drug.
How to fill out nda 021246s-039?
The form must be completed with detailed information about the drug, its efficacy, safety, manufacturing process, and clinical trial data.
What is the purpose of nda 021246s-039?
The purpose is to provide the FDA with all necessary information to evaluate the safety and efficacy of a new drug.
What information must be reported on nda 021246s-039?
Information such as drug composition, clinical trial results, labeling information, and manufacturing process.
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