[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.92]

[Page 128]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents
 
                   Subpart C--Abbreviated Applications
 
Sec. 314.92  Drug products for which abbreviated applications may be submitted.

    Source: 57 FR 17983, Apr. 28, 1992, unless otherwise noted.


    (a) Abbreviated applications are suitable for the following drug 
products within the limits set forth under Sec. 314.93:
    (1) Drug products that are the same as a listed drug. A ``listed 
drug'' is defined in Sec. 314.3. For determining the suitability of an 
abbreviated new drug application, the term ``same as'' means identical 
in active ingredient(s), dosage form, strength, route of administration, 
and conditions of use, except that conditions of use for which approval 
cannot be granted because of exclusivity or an existing patent may be 
omitted. If a listed drug has been voluntarily withdrawn from or not 
offered for sale by its manufacturer, a person who wishes to submit an 
abbreviated new drug application for the drug shall comply with 
Sec. 314.122.
    (2) [Reserved]
    (3) Drug products that have been declared suitable for an 
abbreviated new drug application submission by FDA through the petition 
procedures set forth under Sec. 10.30 of this chapter and Sec. 314.93.
    (b) FDA will publish in the list listed drugs for which abbreviated 
applications may be submitted. The list is available from the 
Superintendent of Documents, U.S. Government Printing Office, 
Washington, DC 20402, 202-783-3238.

[57 FR 17983, Apr. 28, 1992, as amended at 64 FR 401, Jan. 5, 1999]