DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 085583
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 Action | Cytochrome 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: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No |
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