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CENTER FOR DRUG EVALUATION AND RESEARCHAPPLICATION NUMBER:021196Orig1s000 PHARMACOLOGY REVIEW(S)Memorandum:File, NDA 21196Through: Robert Temple, M.D., ODE I Office Director Russell Katz, M.D., Division

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What is file nda 21-196?

NDA 21-196 is a form used for filing a new drug application with the FDA.

Who is required to file file nda 21-196?

Any pharmaceutical company looking to get approval for a new drug must file NDA 21-196.

How to fill out file nda 21-196?

NDA 21-196 must be filled out with detailed information about the new drug, including its composition, intended use, and clinical trial results.

What is the purpose of file nda 21-196?

The purpose of filing NDA 21-196 is to seek approval from the FDA to market and sell a new drug in the United States.

What information must be reported on file nda 21-196?

Information such as drug composition, safety and efficacy data, manufacturing process, and labeling must be reported on NDA 21-196.

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