---
kind: "section"
citation: "21 C.F.R. § 314.152"
title: "21"
number: "314.152"
heading: "Notice of withdrawal of approval of an application or abbreviated application for a new drug."
url: "https://uscodex.org/cfr/21/314.152"
---

# §314.152. Notice of withdrawal of approval of an application or abbreviated application for a new drug.


If the Food and Drug Administration withdraws approval of an application or abbreviated application for a new drug, FDA will publish a notice in the Federal Register announcing the withdrawal of approval. If the application or abbreviated application was withdrawn for grounds described in [§ 314.150(a)](/cfr/21/314.150.md?p=a) or [§ 314.151](/cfr/21/314.151.md), the notice will announce the removal of the drug from the list of approved drugs published under [section 505(j)(6)](/cfr/21/505.md?p=j-6) of the act and shall satisfy the requirement of [§ 314.162(b)](/cfr/21/314.162.md?p=b).


## Notes

### Amendments

[57 FR 17994, Apr. 28, 1992]

### Source

Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted. Redesignated at 57 FR 17983, Apr. 28, 1992.

### 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

[57 FR 17994, Apr. 28, 1992]