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Guidance for industry : alternate source of the active pharmaceutical ingredient in pending ANDAs.

Bibliographic Details
Corporate Author: Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs
Format: Government Document eBook
Language:English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2000]
Subjects:
Drugs > Generic substitution > Government policy > United States.
Drug approval > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS117040
Description
Item Description:"Office of Generic Drugs."
"December 2000."
Electronic resource.
Physical Description:1 online resource (3 pages)