CEFIXIME | N202091 | LUPIN LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lupin Pharmaceuticals, Inc. FDA-2004-P-0477 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 |
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 | — |