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Guidance for industry changes to an approved NDA or ANDA, questions and answers.

Bibliographic Details
Corporate Author:	Center for Drug Evaluation and Research (U.S.)
Format:	Government Document Online Book
Language:	English
Published:	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2001]
Subjects:	Drug approval > United States.
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