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21 C.F.R. § 314.152   Notice of withdrawal of approval of an application or abbreviated application for a new drug.

Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart D—FDA Action on Applications and Abbreviated Applications

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 If the application or abbreviated application was withdrawn for grounds described in §314.150(a) or §314.151, the notice will announce the removal of the drug from the list of approved drugs published under section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