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GUIDANCE DOCUMENT

Revising ANDA Labeling Following Revision of the RLD Labeling April 2000

Download the Final Guidance Document
Final
Docket Number:
FDA-2017-D-6821
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

During the marketing life of a drug product approved under a new drug application (NDA), the package insert labeling is frequently revised. When an NDA serves as an RLD for an ANDA, approved changes in the RLD labeling generally necessitate changes in the labeling of one or more ANDAs using the RLD. Under the Federal Food, Drug, and Cosmetic Act and Agency regulations, an ANDA product must have the same labeling as the RLD.

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All written comments should be identified with this document's docket number: FDA-2017-D-6821.

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