ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | N021123 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2026-P-5984 · 7 docket documents Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Tramadol Hydrochloride and Acetaminophen Tablet 300mg; 25mg suitable for submission in an ANDA, differing in strength from the re | Suitability | 2026-05-27 | Open | Senores Pharmaceuticals, Inc |
Lachman Consultant Sevices, Inc. - Citizen Petition FDA-2013-P-0675 · 3 docket documents Lachman Consultant Services, Inc. filed this petition on June 4, 2013, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Tramadol Hydrochloride 37.5 mg and Acetaminophen 300 mg Tablets suitable for submission as an abbreviated new drug appli | Other | 2013-06-18 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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