21 C.F.R. § 314.152

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

Last amended: 2016Year: 2026Length: 85 wordsOfficial source

Cite as 21 C.F.R. § 314.152 (2026)

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 If the application or abbreviated application was withdrawn for grounds described in § 314.150(a) or § 314.151, the notice will announce the removal of the drug from the list of approved drugs published under section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]
Cross-references to the CFR
314.150314.151314.162
21 C.F.R. § 314.152: Notice of withdrawal of approval of an application or abbreviated application for a new drug. | Justis AI