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 If the application or abbreviated application was withdrawn for grounds described in § 314.150(a) or § 314.151 , the notice will announce the removal of the drug from the list of approved drugs published under section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) .
21 CFR Part 314 · 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
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Amendment history
Federal Register documents that created or amended this section.
- 57 FR 17994 28 Apr 1992