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GUIDANCE DOCUMENT

Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. March 2000

Final
Docket Number:
FDA-2000-D-0781
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is being issued in response to recent litigation and is intended to provide guidance to the pharmaceutical industry regarding (1) the timing of approval of abbreviated new drug applications (ANDAs) following an unsuccessful patent infringement action by the patent owner or new drug application (NDA) holder and (2) the start of 180 days of generic drug exclusivity.


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:

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-2000-D-0781.

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