Guidance for industry court decisions, ANDA approvals, and 180-day exclusivity under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act.

Other Authors: Center for Drug Evaluation and Research (U.S.)
Format: Electronic
Language: English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2000]
Physical Description: 1 online resource (5 pages)
Subjects:
Online Access: https://purl.fdlp.gov/GPO/LPS117068
https://purl.fdlp.gov/GPO/LPS117068

CMU Gov Pub Electronic

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LocationCall Number: Status
CMU Gov Pub Electronic HE 20.4702:EX 2/2 Available