Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.

Bibliographic Details
Corporate Author: Center for Drug Evaluation and Research (U.S.)
Format: Government Document eBook
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004]
Online Access:


Available Online

Holdings details from Available Online
Call Number: HE 20.4702:N 42/3
Call Number Status Get It
HE 20.4702:N 42/3 Available