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TOLECTIN

NDA

TOLMETIN SODIUM | N017628 | ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC

2 strengths0 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

No FDA citizen petitions matched from Regulations.gov

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 -68	View Letter (PDF)
Feb 22, 2006	SUPPL -67	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 200MG BASE

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — EQ 600MG BASE

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 8, 1989