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Guidance Documents/Guidance/Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act

Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act

Detailed guidance document from FDA and regulatory agencies.

Document Details

Unknown

March 27, 2000

December 1, 2018

Center for Drug Evaluation and Research

4d91b564-120c-4376-be51-25fecf8aa7a3

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