Viewing data from:

QUINAGLUTE

NDA

QUINIDINE GLUCONATE | N016647 | BAYER HEALTHCARE 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 DMF8 inactive

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

BUCHLER GMBHQUINIDINE GLUCONATE

DMF 325272018

SOCIETE CHIMIQUE POINTET GIRARD SAInactiveQUINIDINE GLUCONATE

DMF 27231976

DSM MINERA BVInactiveQUINIDINE GLUCONATE USP XIX

DMF 32411978

ROCHE DIAGNOSTICS GMBHInactiveQUINIDINE GLUCONATE & SULFATE USP XIX (BULK) & BP 1973

DMF 33551978

ISLAND CHEMICAL CO INCInactiveQUINIDINE GLUCONATE

DMF 36971980

SCHERING AGInactiveQUINIDINE GLUCONATE

DMF 50621983

FOREST LABORATORIES INCInactiveQUINIDINE GLUCONATE 650 MG. C.R. TABLETS

DMF 59041985

LEIRAS PHARMACEUTICALSInactiveQUINIDINE GLUCONATE EXTENDED RELEASE GRANULES

DMF 72921988

PT SINKONA INDONESIA LESTARIInactiveQUINIDINE GLUCONATE

DMF 123341997

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

Products (1)

#001 — 324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.