ACETAMINOPHEN; HYDROCODONE BITARTRATE | A040084 | MALLINCKRODT CHEMICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Russ Pharmaceuticals, Inc. FDA-1985-P-0501 Russ Pharmaceuticals, Inc. filed this petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting a determination that its proposed liquid analgesic product containing 2.5 mg hydrocodone bitartrate and 165 mg acetaminophen per teaspoonful is suitable for evaluation under an abb | Other | 2025-06-27 | Granted | Russ Pharmaceuticals |
Citizen Petition from Russ Pharmaceuticals, Inc. FDA-1985-P-0501 Russ Pharmaceuticals, Inc. submitted a Section 505 citizen petition requesting that the FDA declare a drug product suitable for an abbreviated new drug application (ANDA). The product is a tablet containing 2.5 milligrams of hydrocodone bitartrate and 500 milligrams of acetaminophen indicated for re | Other | 2025-06-27 | Granted | Russ Pharmaceuticals |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0302 Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Hydrocodone Bitartrate and Acetaminophen Effervescent Tablets in strengths of 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 | Other | 2011-05-25 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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