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GUIDANCE DOCUMENT

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs January 2019

Draft

Not for implementation. Contains non-binding recommendations.

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

Docket Number:
FDA-2018-D-4726
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs.” This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest lawful approval date.


Submit Comments

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:

Division of Dockets Management (HFA- 305)
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-2018-D-4726.