21 CFR § 314.97 - Supplements and other changes to an approved ANDA.

---
identifier: "/us/cfr/t21/s314.97"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 314.97 - Supplements and other changes to an approved ANDA."
title_number: 21
title_name: "Food and Drugs"
section_number: "314.97"
section_name: "Supplements and other changes to an approved ANDA."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "314"
part_name: "APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1."
regulatory_source: "50 FR 7493, Feb. 22, 1985, unless otherwise noted."
cfr_part: "314"
---


# 314.97 Supplements and other changes to an approved ANDA.

(a) *General requirements.* The applicant must comply with the requirements of §§ 314.70 and 314.71 regarding the submission of supplemental ANDAs and other changes to an approved ANDA.

(b) *Different listed drug.* An applicant may not supplement an ANDA to seek approval of a drug referring to a listed drug that is different from the current reference listed drug identified in the ANDA. This paragraph (b) applies if changes are proposed in a supplement to the ANDA such that the proposed product is a pharmaceutical equivalent to a different listed drug than the reference listed drug identified in the ANDA. A change of reference listed drug must be submitted in a new ANDA. However, notwithstanding the limitation described in this paragraph (b), an applicant may supplement the ANDA to seek approval of a different strength.

[81 FR 69653, Oct. 6, 2016]