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TRECATOR

NDA

ETHIONAMIDE | N013026 | WYETH PHARMACEUTICALS LLC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs3 inactive

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

ORGAPHARM SASETHIONAMIDE DRUG SUBSTANCE

DMF 236402010

APICHEM LABORATORIES PRIVATE LTDETHIONAMIDE USP

DMF 381942023

RHODIA INCInactiveETHIONAMIDE

DMF 4351961

GEDEON RICHTER LTDInactiveETHIONAMIDE

DMF 56041984

RHONE POULENC RORER PHARMACEUTICALS INCInactiveETHIONAMIDE SUPPOSITORIES, 500 MG, THERAPLIX SA, PARIS, FR

DMF 80101989

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

Approval Letters

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#002 — 250MG

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.