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Covington
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Mallinckrodt

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085583

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NDA 085583 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 085583
Tradename:QUINIDINE SULFATE
Applicant:Watson Labs
Ingredient:quinidine sulfate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 085583
Mechanism of ActionCytochrome P450 2D6 Inhibitors
Suppliers and Packaging for NDA: 085583
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUINIDINE SULFATE quinidine sulfate TABLET;ORAL 085583 ANDA Watson Laboratories, Inc. 0591-5454 N 0591-5454-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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US Department of Justice
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Fish and Richardson
Fuji
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