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Title 21: Food and Drugs
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.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 If the application or abbreviated application was withdrawn for grounds described in ? 314.150(a) or ? 314.151, the notice will announce the removal of the drug from the list of approved drugs published under section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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