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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-6821.