21 CFR § 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug.

---
identifier: "/us/cfr/t21/s314.152"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug."
title_number: 21
title_name: "Food and Drugs"
section_number: "314.152"
section_name: "Notice of withdrawal of approval of an application or abbreviated application for a new drug."
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"
---


# 314.152 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 If the application or abbreviated application was withdrawn for grounds described in § 314.150(a) or § 314.151, the notice will announce the removal of the drug from the list of approved drugs published under section 505(j)(6) of the act and shall satisfy the requirement of § 314.162(b).

[57 FR 17994, Apr. 28, 1992]