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U.S. Department of Health and Human Services


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Suitability Petitions

The following are abbreviated lists of Petitions filed (after March 31, 1999)  under section 505(j)(2)(C) of the Food, Drug and Cosmetic Act where the Agency has determined that the referenced product: (1) Is suitable for submission as an ANDA (Petitions Approved ), (2) Is not suitable for submission as an ANDA (Petitions Denied), (3) the petition has been withdrawn (Petition Withdrawn), or (4) the petition is still pending (Petition Pending).

The determination that an ANDA will be approved is not made until the ANDA itself is submitted and reviewed by the Agency. A copy of each Petition is listed by Docket number on public display in FDA's Division of Dockets Management, HFA-305, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852.