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US Department of Justice
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US Army

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088072

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NDA 088072 describes QUINIDINE SULFATE, which is a drug marketed by Lilly, G And W Labs Inc, Barr, Contract Pharmacal, Cycle Pharms Ltd, Dava Pharms Inc, Elkins Sinn, Everylife, Halsey, Hikma Pharms, Impax Labs, Ivax Sub Teva Pharms, King Pharms, Kv Pharm, Lannett, Lederle, Perrigo, Pharmavite, Purepac Pharm, Sandoz, Scherer Labs, Sun Pharm Industries, Superpharm, Usl Pharma, Valeant Pharm Intl, Vangard, Vintage Pharms, Warner Chilcott, Watson Labs, and Whiteworth Town Plsn, and is included in forty NDAs. It is available from three suppliers. Additional details are available on the QUINIDINE SULFATE profile page.

The generic ingredient in QUINIDINE SULFATE is quinidine sulfate. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the quinidine sulfate profile page.
Summary for 088072
Ingredient:quinidine sulfate
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 088072
Suppliers and Packaging for NDA: 088072
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUINIDINE SULFATE quinidine sulfate TABLET;ORAL 088072 ANDA Eon Labs, Inc. 0185-1047 N 0185-1047-01
QUINIDINE SULFATE quinidine sulfate TABLET;ORAL 088072 ANDA Eon Labs, Inc. 0185-1047 N 0185-1047-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Sep 26, 1983TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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