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Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 5 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER D - DRUGS FOR HUMAN USE / PART 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG / Subpart D - FDA Action on Applications and Abbreviated Applications / § 314.152 Notice of withdrawal of approval of an application or abbreviated application for a new drug.
§ 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 If the application or abbreviated application was withdrawn for grounds described in § 314.150(a) or § 314.151, the notice will announce the removal of the drug from the list of approved drugs published under section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]
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