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GUIDANCE DOCUMENT

Variations in Drug Products that May Be Included in a Single ANDA December 1998

Download the Final Guidance Document
Final
Docket Number:
FDA-2021-D-0385
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to provide information to applicants on certain specific variations of a drug product that should be included in a single abbreviated new drug application (ANDA) and describe the general factors to be considered when determining whether single or multiple ANDAs should be submitted.

Submit Comments

Submit Comments Online

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:

Dockets Management
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-2021-D-0385.

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