21 CFR Part 314 · Applications for FDA Approval to Market a New Drug

§ 314.97 Supplements and other changes to an approved ANDA

Subpart C - Abbreviated Applications Official text on eCFR Amendment history

(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.

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Warning letters citing § 314.97

1 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 314.97

and 16 more.

Amendment history

Federal Register documents that created or amended this section.