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NDA

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | N021123 | JANSSEN PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2026-P-5984 Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to 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 in strengths of 300mg and 25mg, which d	Suitability	2026-05-27	Open	Senores Pharmaceuticals

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Feb 14, 2023	SUPPL -15	View Letter (PDF)
Sep 14, 2021	SUPPL -21	View Letter (PDF)
Mar 5, 2021	SUPPL -20	View Letter (PDF)
Oct 8, 2019	SUPPL -19	View Letter (PDF)
Sep 28, 2018	SUPPL -17	View Letter (PDF)
Sep 28, 2018	SUPPL -16	View Letter (PDF)
Aug 30, 2017	SUPPL -14	View Letter (PDF)
Dec 20, 2016	SUPPL -13	View Letter (PDF)
Dec 20, 2016	SUPPL -10	View Letter (PDF)
Dec 20, 2016	SUPPL -12	View Letter (PDF)
Oct 21, 2013	SUPPL -8	View Letter (PDF)
Jun 28, 2011	SUPPL -5	View Letter (PDF)
Nov 10, 2009	SUPPL -3	View Letter (PDF)
Apr 20, 2004	SUPPL -1	View Letter (PDF)
Aug 15, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 15, 2001

No patent or exclusivity listings for this strength.