[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.152]

[Page 155]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 314_APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--
Table of Contents
 
    Subpart D_FDA Action on Applications and Abbreviated Applications
 
Sec. 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If the application or abbreviated application was withdrawn for grounds 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 Sec. 314.150(a) or Sec. 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 Sec. 
314.162(b).

[57 FR 17994, Apr. 28, 1992]