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TOLECTIN DS

NDA

TOLMETIN SODIUM | N018084 | ORTHO MCNEIL 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

7 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-7180 · 11 docket documents Senores Pharmaceuticals, Inc. filed a suitability petition requesting that the FDA recognize a drug substance as suitable for use in pharmaceutical products, establishing that the substance meets established standards for identity, strength, quality, purity, and potency to support its use in ANDA su	Suitability	2026-06-29	Open	Senores Pharmaceuticals, Inc.
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-1833 · 8 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 Tolmetin Capsules 600 mg, which would differ in strength from the reference listed drug Tolec	Suitability	2026-02-19	GrantedNo FDA response document on docket	Senores Pharmaceuticals, Inc.
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-1820 · 8 docket documents Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Tolmetin Capsules 200 mg is suitable for submission in an Abbreviated New Drug Application (ANDA), with the reference listed dru	Suitability	2026-02-19	Open	Senores Pharmaceuticals, Inc.
Citizen Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-3575 · 4 docket documents Senores Pharmaceuticals, Inc. filed this ANDA citizen petition requesting that the FDA determine whether TOLECTIN DS (Tolmetin Capsules 200 mg), approved under NDA 018084 and held by Ortho McNeil Janssen Pharmaceuticals Inc., was withdrawn from the market for reasons of safety or effectiveness, or a	505(q)	2025-09-11	GrantedNo FDA response document on docket	Senores Pharmaceuticals, Inc.
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1454 · 8 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 FDA authorization to submit an Abbreviated New Drug Application for Tolmetin Capsules 600 mg, a nonsteroidal anti-inflammatory drug that differs in st	Suitability	2025-05-30	DeniedDecision letter not yet read	Senores Pharmaceuticals, Inc.
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1452 · 8 docket documents Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act to request FDA determination that Tolmetin Capsules 200 mg is suitable for submission in an Abbreviated New Drug Application, allowing the company to submit an ANDA fo	Suitability	2025-05-30	DeniedDecision letter not yet read	Senores Pharmaceuticals, Inc.
Citizen Petition from Quantum Pharmics, Ltd. FDA-1990-P-0044 · 6 docket documents Quantum Pharmics, Ltd. filed this citizen petition under section 505(j)(2)(c) of the Federal Food and Drug Act on January 9, 1990, requesting permission to file an Abbreviated New Drug Application for Tolmetin Sodium Tablets, USP, 400 mg, which differs from the listed drug Tolectin 600 (tolmetin sod	Other	2017-07-17	GrantedUnverified summary	Quantum Pharmics, Ltd.

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF11 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MATRIX PHARMACORP PRIVATE LTDTOLMETIN SODIUM USP

DMF 220922008

ETHYL CORPInactiveTOLMETIN (MCN2559-21-98)

DMF 22941974

ETHYL CORPInactiveTOLMETIN (MCN 2559-21-98)

DMF 25141975

CILAG CHEMIE AGInactiveTOLMETIN SODIUM DIHYDRATE

DMF 25371975

MALLINCKRODT INCInactiveTOLMETIN SODIUM DIHYDRATE

DMF 27631976

MALLINCKRODT INCInactiveTOLMETIN SODIUM DIHYDRATE T.A.

DMF 27901976

ORGANICHEM CORPInactiveTOLMETIN SODIUM DIHYDRATE

DMF 41091981

NORAMCO INCInactiveTOLMETIN SODIUM DIHYDRATE

DMF 44411981

ORION CORP LTDInactiveTOLMETIN SODIUM

DMF 67831986

ALFA CHEMICALS ITALIANA SRLInactiveTOLMETIN SODIUM DIHYDRATE

DMF 72701987

COSMA SPAInactiveTOLMETIN SODIUM

DMF 73361988

AMSA SPAInactiveTOLMETIN SODIUM

DMF 164322003

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 24, 2008	SUPPL -52	View Letter (PDF)
Feb 22, 2006	SUPPL -51	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.