Approved NDA or ANDA

U.S. Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Guidance for industry Changes to an approved NDA or ANDA, available http //www.fda.gov/cder/guidance/3516fnl.pdf, accessed Apr. 15,2006. 

CDER-approved products are considered those subject to an approved NDA or ANDA. Some information on which components/materials aie used in CDER-approved products is available from the Agency (e.g., FDA, CDER, Inactive Ingredient Guide, 1996, Division of Drug Information Resources). When infonnation is not available, an applicant should use reliable sources of infonnation to determine that the component or material has been used in and has been in contact with a CDER-approved product of the same dosage form and route of administration, as appropriate. The applicant should identify in the supplement or annual report the basis for the conclusion that the component or material is used in a CDER-approved product. 

Changes in nonsterile semisolid dosage forms should be reviewed against the November 1999 FDA guidance for industry Changes to an Approved NDA or ANDA and the SUPAC Guidance for Industry Nonsterile Semisolid Dosage... 

CMCCC, CDER, FDA. Guidance for Industry—Changes to an Approved NDA or ANDA. Drug Information Branch, CDER, FDA (November 1999). 

FDA guidelines for Scale-up and Postapproval Changes (SUPAC) and changes to an approved NDA or ANDA. 

GUIDANCE FOR INDUSTRY1—CHANGES TO AN APPROVED NDA OR ANDA SPECIFICATIONS—USE OF ENFORCEMENT DISCRETION FOR COMPENDIAL CHANGES... 

Changes to an Approved NDA or ANDA US, DHHS, FDA, Center for Drug Evaluation and Research (CDER) Nov 1999 FDA Guidance for Industry. 

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