CEFIXIME | N202091 | LUPIN LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lupin Pharmaceuticals, Inc. FDA-2004-P-0477 · 4 docket documents Lupin Pharmaceuticals, Inc. filed this citizen petition under 21 CFR 10.20 and 10.30 and Section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Cefixime Chewable Tablets in 100 mg, 150 mg, and 200 mg strengths suitable for submission as an abbreviated new dr | Other | 2016-06-17 | Granted | Lupin Pharmaceuticals, Inc. |
Lupin Pharmaceuticals, Inc. (Buc & Beardsley, LLP) - Citizen Petition FDA-2009-P-0522 · 3 docket documents Lupin Pharmaceuticals, Inc. filed this citizen petition under sections 505(j) and 505(q) requesting that the FDA not approve any ANDA for cefixime for oral suspension referencing Lupin's Suprax product unless the applicant meets the same standards for strength, potency, quality, impurities, stabilit | 505(q) | 2009-10-28 | Granted | — |
Lupin Pharmaceuticals, Inc. - Citizen Petition FDA-2007-P-0185 · 4 docket documents Lupin Pharmaceuticals, Inc. filed this suitability petition on October 16, 2007, requesting that the FDA declare Cefixime for Oral Suspension, 100 mg/mL, suitable for submission as an abbreviated new drug application (ANDA) under Section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act. The | Other | 2008-05-06 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9233112 | Dec 14, 2028 | — | — | Yes | — |