Details for New Drug Application (NDA): 088072
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NDA 088072 describes QUINIDINE SULFATE, which is a drug marketed by Lilly, Cosette, Barr, Chartwell Molecular, Contract Pharmacal, Cycle, Dava Pharms Inc, Elkins Sinn, Epic Pharma Llc, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, King Pharms, Kv Pharm, 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 two 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. Two suppliers are listed for this compound. 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. Two suppliers are listed for this compound. Additional details are available on the quinidine sulfate profile page.
Summary for 088072
| Tradename: | QUINIDINE SULFATE |
| Applicant: | Epic Pharma Llc |
| Ingredient: | quinidine sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 088072
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors |
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 | 0185-1047-01 | 100 TABLET in 1 BOTTLE (0185-1047-01) |
| QUINIDINE SULFATE | quinidine sulfate | TABLET;ORAL | 088072 | ANDA | Eon Labs, Inc. | 0185-4346 | 0185-4346-01 | 100 TABLET in 1 BOTTLE (0185-4346-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Sep 26, 1983 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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