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GUIDANCE DOCUMENT

180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day July 2003

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
2003D-0325
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day.” This guidance explains how FDA intends to determine eligibility for 180-day exclusivity when multiple substantially complete abbreviated new drug applications (ANDAs) that contain a paragraph IV certification to the same patent(s) are submitted on the same day or when paragraph IV certifications are submitted in an amendment or supplement on the same day.

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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: 2003D-0325.

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