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