Food and Drug Administration codes

Codes are published by the FDA for every multisource product listed in the Orange Book (listing of the approved drug products). The two basic clas-sificationsinto which multi-sourcedmgshavebeen placed are indicated by the first letter of the code  

A drug products that the FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products 

B drug products that the FDA does not consider, at this time, to be therapeutically equivalent to other pharmaceutically equivalent products (i.e. drug products for which actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence). 

No known or suspected bioequivalence problems These are designated as AA, AN, 

AA for conventional dosage forms AN for aerosol products AO for injectable oil solutions AP for injectable aqueous solutions AT for topical products. 

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US Food and Drug Administration, Code of Federal Regulations 21, 1995. 

FDA. 1977a. Indirect food additives Adhesives and components of coatings. U.S. Food and Drug Administration. Code of Federal Regulations. 21 CFR 175.105. 

U.S. Food and Drug Administration, Code of Federal Regulation, Title 21, Part 556, Sections 150, 500, and 720, US Government Printing Office, Washington, DC, 2003, Chap. 1 http //www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm fr=556.500 (April 30, 2005). 

FDA (2001) Food And Drug Administration Code of Federal Regulations, Title 21, Vol 6, Revised as of 1 April, 2001, p. 515. From the US Government Printing Office via GPO Access [CITE 21CFR582.80],... 

US Food and Drug Administration Code of Federal Regulations (2004), Part 2II, Current good manufacturing practice for finished pharmaceuticals, YiiXe 21, vol. 4, subparts E, F, G and I. 

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