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Details for New Drug Application (NDA): 088072

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NDA 088072 describes QUINIDINE SULFATE, which is a drug marketed by Lilly, Purepac Pharm, Contract Pharmacal, Vangard, Dava Pharms Inc, Sandoz, Elkins Sinn, Perrigo, Pharmavite, Sun Pharm Inds, Cycle Pharms Ltd, Usl Pharma, Everylife, Watson Labs, Lannett, Whiteworth Town Plsn, G And W Labs Inc, Impax Labs, Ivax Sub Teva Pharms, Hikma Pharms Llc, Vintage Pharms, Scherer Labs, Superpharm, King Pharms, Kv Pharm, Lederle, Barr, Warner Chilcott, Halsey, and Valeant Pharm Intl, 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-six 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 NDA: 088072

quinidine sulfate
Therapeutic Class:Cardiovascular Agents

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
TABLET;ORAL 088072 ANDA Eon Labs, Inc. 0185-1047 0185-1047-01 100 TABLET in 1 BOTTLE (0185-1047-01)
quinidine sulfate
TABLET;ORAL 088072 ANDA Eon Labs, Inc. 0185-1047 0185-1047-10 1000 TABLET in 1 BOTTLE (0185-1047-10)

Summary for product number 001

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

Summary 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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