approval history
- Guideline or reference source
- FDA www.fda.gov
- Definition
- 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
- Related Term
- approval
- authorization status
Send comments to info@celegence.com Please read disclaimer before using Qsauri.