---
kind: "section"
citation: "21 C.F.R. § 314.97"
title: "21"
number: "314.97"
heading: "Supplements and other changes to an approved ANDA."
url: "https://uscodex.org/cfr/21/314.97"
---

# §314.97. Supplements and other changes to an approved ANDA.

- (a) **General requirements.** The applicant must comply with the requirements of §§ [314.70](/cfr/21/314.70.md) and [314.71](/cfr/21/314.71.md) 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)](#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)](#b), an applicant may supplement the ANDA to seek approval of a different strength.

## Notes

### Amendments

[81 FR 69653, Oct. 6, 2016]

### Source

Source: 57 FR 17983, Apr. 28, 1992, unless otherwise noted.

### Authority

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.

### Source

Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.

### Amendments

[81 FR 69653, Oct. 6, 2016]