What is an ANDA? FDA generic drug application requirements
An ANDA is an abbreviated new drug application for FDA review of a generic drug. Learn what applicants must show and how it differs from an NDA.
What is an ANDA?
An ANDA is an abbreviated new drug application submitted to the US FDA for review and potential approval of a generic drug. It is "abbreviated" because applicants generally don't repeat the animal and human studies that established the reference drug's safety and effectiveness. They must still provide evidence supporting their generic product, including bioequivalence. FDA's ANDA overview explains this approach.
An ANDA is an application, not an approval. Submitting one does not mean FDA has approved the drug. The application must include quality, manufacturing, labeling and other required information under 21 CFR 314.94.
NDA vs ANDA and the meaning of abbreviated
The distinction concerns the evidence submitted. FDA describes the ANDA pathway as relying on existing findings of safety and effectiveness rather than repeating the studies that established them. But "abbreviated" does not mean no human studies: applicants must support bioequivalence, which can involve studies in people. See FDA's explanation.
An NDA is described under section 314.50, while an ANDA is described under section 314.94. The informal term "abbreviated NDA" does not change those separate application requirements. See the definitions in 21 CFR 314.3.
What must a generic drug demonstrate?
An ANDA identifies a reference listed drug, or RLD. This is the listed drug FDA identifies as the product on which the applicant relies. The reference standard has a different role: it is FDA's selected product for the in vivo bioequivalence comparison. The terms are not interchangeable under FDA's definitions.
Under section 314.94(a), applicants must show that the generic has the same active ingredients, route of administration, dosage form and strength as the RLD. Specified exceptions require an approved suitability petition. Its proposed conditions of use must have been approved for the RLD. The application must also contain bioequivalence evidence.
Labeling must be the same except for permitted differences, which the applicant must explain. Inactive ingredients need not always be identical. Differences must meet applicable requirements, and some dosage forms have stricter rules. Don't assume an excipient change is acceptable simply because the active ingredient remains the same. These requirements are set out in section 314.94.
What does an FDA ANDA application contain?
The submission includes more than bioequivalence results. For a practical starting checklist, section 314.94 requires:
- A signed application form, contents list and basis for submission identifying the RLD.
- Information supporting the proposed conditions of use and required product sameness.
- Bioequivalence evidence, study information and applicable human-subject compliance statements.
- Reference and proposed labeling, with an annotated side-by-side comparison explaining differences.
- Chemistry, manufacturing and controls information, including inactive-ingredient information.
- Applicable patent certifications or statements, plus required financial certification or disclosure.
This is a condensed checklist. The section also addresses samples information, other cross-referenced information and submission format. Physical samples are provided when FDA requests them. Use the full regulatory requirements when planning a submission.
Does an ANDA guarantee approval?
No. Some proposed differences require an approved suitability petition; don't assume every modified product qualifies for an ANDA. An approved petition does not replace the remaining application requirements in section 314.94.
RegAffairs AI answers "What is an ANDA?" with links to regulatory sources.
Tentative approval means an application otherwise meets approval requirements but cannot yet receive approval, for example because of patent, exclusivity or court-order barriers. A tentatively approved drug is not an approved drug under 21 CFR 314.3.