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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993NDA 209381 NDA APPROVAL Forging BV Attention: Santa Chain Patel Regulatory Affairs Project Manager US agent
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What is nda 209381 nda approval?
NDA 209381 is a New Drug Application approval from the FDA.
Who is required to file nda 209381 nda approval?
The pharmaceutical company seeking approval for a new drug is required to file NDA 209381.
How to fill out nda 209381 nda approval?
To fill out NDA 209381, the company must provide detailed information about the new drug, including data from clinical trials and safety studies.
What is the purpose of nda 209381 nda approval?
The purpose of NDA 209381 approval is to allow the new drug to be marketed and sold to the public.
What information must be reported on nda 209381 nda approval?
Information reported on NDA 209381 includes details about the new drug's safety, efficacy, chemical composition, and proposed labeling.
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