What Is an ANDA

An ANDA (abbreviated new drug application) is the US FDA application for approval of a generic drug. It is "abbreviated" because, in FDA's words, applicants "are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness." Instead, the applicant relies on an approved reference drug and shows that its product performs the same way.

Legal definition (21 CFR 314.3). "Abbreviated application, abbreviated new drug application, or ANDA is the application described under § 314.94, including all amendments and supplements to the application." The full NDA is a separate application, described under § 314.50. eCFR 21 CFR 314.3

What an ANDA relies on and must show

• Reference listed drug (RLD): "the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA." Whether a drug counts as a listed drug depends on whether it appears in FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). FDA says the Orange Book lists all approved products, both innovator and generic. eCFR 314.3; FDA ANDA page
• Bioequivalence: defined as "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety ... becomes available at the site of drug action" at the same molar dose, in an appropriately designed study. FDA explains that the generic must "deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug." For in vivo bioequivalence studies, the applicant "must use" the reference standard that FDA selects.
• Therapeutic equivalence: therapeutic equivalents are pharmaceutical equivalents (same active ingredient, dosage form, route and amount) "for which bioequivalence has been demonstrated." They can be expected to have the same clinical effect and safety profile.

Related terms defined in the same section

• ANDA holder: the applicant that owns an approved ANDA.
• Paragraph IV certification: a patent certification of invalidity, unenforceability or noninfringement, made under § 314.94(a)(12)(i)(A)(4).
• First applicant and the 180-day exclusivity period: the first applicant is the first to submit a substantially complete ANDA with a paragraph IV certification. The 180-day exclusivity period runs from the first commercial marketing by any first applicant.
• Tentative approval: the ANDA otherwise meets the approval requirements but cannot yet be approved, for example because of patent, exclusivity or court-order barriers. A tentatively approved product "is not an approved drug."

The eCFR version I read is current to 30 October 2026. It flags an amendment to § 314.3 published at 91 FR 60003 on 22 September 2026, which I did not open.

Approach: I read the official eCFR text of 21 CFR 314.3 and FDA's ANDA overview page. I couldn't reach the Part 314 regulations in our own datasets this time, so § 314.94 (the content and format requirements for an ANDA) is cited above but its text was not reviewed.