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 under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Tramadol Hydrochloride and Acetaminophen Tablet at proposed strengths of 300 mg and 25 mg, wh | 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mg and Acetaminophen 300 mg Tablets suitable for submission as an abbreviated new drug appli | Other | 2013-06-18 | Withdrawn | — |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.
No patent or exclusivity listings for this strength.