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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration Silver Spring MD 20993NDA 21894/S013 SUPPLEMENT APPROVAL Valiant Pharmaceuticals North America, LLC Attention: Jennifer S. Nicola,

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What is nda 21894s-013?

NDA 21894s-013 is a form submitted to the regulatory agency for approval of a new drug application.

Who is required to file nda 21894s-013?

Pharmaceutical companies or drug manufacturers are required to file NDA 21894s-013.

How to fill out nda 21894s-013?

NDA 21894s-013 must be filled out with detailed information about the new drug, including its efficacy and safety data.

What is the purpose of nda 21894s-013?

The purpose of NDA 21894s-013 is to seek approval from the regulatory agency to market and sell a new drug.

What information must be reported on nda 21894s-013?

Information such as preclinical and clinical data, manufacturing process, labeling, and proposed indications must be reported on NDA 21894s-013.

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