Home > Term: approval history
approval history
The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). There are over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product.
- Part of Speech: noun
- Industry/Domain: Pharmaceutical
- Category: Drugs
- Company: U.S. FDA
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Creator
- DanielFarris
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(United States)