GUIDANCE DOCUMENT
Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry Draft Guidance for Industry January 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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All written comments should be identified with this document's docket number: FDA-2022-D-0092
- Docket Number:
- FDA-2022-D-0092
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling following revisions to the approved labeling of a reference listed drug (RLD). This guidance provides recommendations on identifying RLD labeling updates and submitting ANDA amendments or supplements to update generic drug labeling. This guidance revises the guidance for industry Revising ANDA Labeling Following Revision of the RLD Labeling (April 2000). After it has been finalized, this guidance will replace the April 2000 guidance. Significant changes from the 2000 version include updates to outdated details about how to obtain information on changes to RLD labeling and how to submit revised ANDA labeling to FDA.