Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs: Guidance for Industry - FDA Guidance Document | Global Key Solutions

Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs: Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Document Type

Guidance Document

Issue Date

December 1, 2000

Last Updated

April 21, 2020

Office

Center for Drug Evaluation and Research

Document ID

8a3da1bc-1ebb-48aa-a3ea-7662562c4370

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