Abbreviated new drug application (ANDA) number
What is the abbreviated new drug application (ANDA) number?
The abbreviated new drug application (ANDA) number is a six-digit number assigned by FDA staff to each ANDA. An ANDA is an application containing data for the review and ultimate approval of a generic drug product by the Food & Drug Administration. ANDAs are “abbreviated” because they do not require clinical and nonclinical data to establish safety and effectiveness; instead, the applicant must demonstrate that the product is bioequivalent to an innovator drug.
In addition to the ANDA, these applications are also assigned a number:
- New Drug Application (NDA)
- New Animal Drug Application (NADA)
- Biological License Application (BLA)
- Abbreviated New Animal Drug Application (ANADA)
How can ANDA numbers be used?
Users can search DailyMed by ANDA number but must include “ANDA” before the number. For example, they might search for ANDA100304. The application number makes it easier to sort and retrieve drug information, especially when there are similar drugs.