ANDA
Medical abbreviation · Pharmacy
| Stands for | Abbreviated New Drug Application |
|---|---|
| Categories | Medical |
ANDA stands for Abbreviated New Drug Application, a pharmacy abbreviation.
FDA pathway for approval of generic drugs. Instead of repeating clinical trials, the applicant shows the generic is pharmaceutically equivalent and bioequivalent to an approved reference drug.
Example: Three manufacturers hold ANDAs for the generic, so the price has dropped sharply.
Usage notes
The pathway was created by the 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman). The first generic company to successfully challenge a brand's patent can earn 180 days of marketing exclusivity. Approved generics and their equivalence ratings appear in the FDA's Orange Book.
Related abbreviations
More pharmacy abbreviations
- 1/2NS – Half-normal saline
- AB – Therapeutically equivalent rating (Orange Book code)
- ADC – Automated dispensing cabinet
- ADF – Abuse-deterrent formulation
- AHFS – American Hospital Formulary Service
- amp – Ampule
- APhA – American Pharmacists Association
- API – Active pharmaceutical ingredient
- aq – Aqueous
- ARCOS – Automation of Reports and Consolidated Orders System
- ASHP – American Society of Health-System Pharmacists
- AWP – Average wholesale price
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This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.