[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: 21CFR314.97]

[Page 134]
 
                        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 C_Abbreviated Applications
 
Sec. 314.97  Supplements and other changes to an approved abbreviated
application.

    The applicant shall comply with the requirements of Sec. Sec. 
314.70 and 314.71 regarding the submission of supplemental applications 
and other changes to an approved abbreviated application.