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NDA 20839 / S044 Page 4PLAVIX bi sulfate tablets DESCRIPTION (bi sulfate) is an inhibitor of ADP induced platelet aggregation acting by direct inhibition of adenosine diphosphate (ADP) binding to

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What is nda 20-839 s-044?

NDA 20-839 s-044 is a specific form used for submitting new drug application to the FDA.

Who is required to file nda 20-839 s-044?

Any pharmaceutical company or drug manufacturer seeking approval for a new drug must file nda 20-839 s-044.

How to fill out nda 20-839 s-044?

NDA 20-839 s-044 must be filled out accurately and completely, including information on the drug's efficacy, safety, and manufacturing process.

What is the purpose of nda 20-839 s-044?

The purpose of nda 20-839 s-044 is to provide the FDA with necessary information to evaluate the safety and efficacy of a new drug before approving it for market.

What information must be reported on nda 20-839 s-044?

Information on the drug's formulation, manufacturing process, preclinical and clinical studies, adverse reactions, and labeling must be reported on nda 20-839 s-044.

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