ACETAMINOPHEN; CODEINE PHOSPHATE | A040223 | DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Mikart, Incorporated FDA-1996-P-0154 · 9 docket documents Mikart, Incorporated filed this citizen petition under 21 U.S.C. 505(j)(2)(C) requesting that the FDA Commissioner determine whether Acetaminophen and Codeine Phosphate Tablets USP 325 mg/45 mg manufactured by KV Pharmaceuticals was discontinued from marketing for safety or effectiveness reasons, as | 505(q) | 2017-08-29 | Granted | Mikart, Incorporated |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0167 · 3 docket documents Lachman Consultant Services, Inc., on behalf of a client, filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Butalbital and Acetaminophen Capsules 50 mg/300 mg suitable for submission as an abbreviated new drug applicati | Other | 2011-03-25 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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