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QUINIDEX

NDA

QUINIDINE SULFATE | N012796 | WYETH 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF7 inactive

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

BUCHLER GMBHQUINIDINE SULFATE

DMF 36771979

BUCHLER AND COInactiveQUINIDINE SULFATE AND QUINIDINE PRODUCTS

DMF 27591976

PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKSInactiveQUINIDINE SULFATE

DMF 28711977

SOCIETE CHIMIQUE POINTET GIRARD SAInactiveQUINIDINE SULFATE

DMF 29021977

DSM MINERA BVInactiveQUINIDINE SULFATE

DMF 33891978

ISLAND CHEMICAL CO INCInactiveQUINIDINE SULFATE USP XX

DMF 37031980

ELAN CORP PLCInactiveQUINIDINE SULFATE SUSTAINED ACTION PELLETS

DMF 61251985

PT SINKONA INDONESIA LESTARIInactiveQUINIDINE SULFATE

DMF 96321992

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 21, 2002	SUPPL -49	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 300MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.