21 CFR § 314.152 Applications for FDA Approval to Market a New Drug

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

Current through Sep 8, 2026 · Read all of Part 314

⚠ 4 pending changes to Part 314

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 If the application or abbreviated application was withdrawn for grounds described in § 314.150(a) or § 314.151, the notice will announce the removal of the drug from the list of approved drugs published under section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]

← § 314.151 Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.§ 314.153 Suspension of approval of an abbreviated new drug application. →