ACETAMINOPHEN; CODEINE PHOSPHATE | A040098 | DAVA PHARMACEUTICALS 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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