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Revising ANDA Labeling Following Revision of the RLD Labeling April 2000

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.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.