Details for New Drug Application (NDA): 089338
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NDA 089338 describes QUINIDINE GLUCONATE, which is a drug marketed by Lilly, Ani Pharms, Ascot, Cycle, Halsey, Hibrow Hlthcare, Rising, Sun Pharm Industries, Superpharm, and Watson Labs, and is included in ten NDAs. It is available from four suppliers. Additional details are available on the QUINIDINE GLUCONATE profile page.
The generic ingredient in QUINIDINE GLUCONATE is quinidine gluconate. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the quinidine gluconate profile page.
The generic ingredient in QUINIDINE GLUCONATE is quinidine gluconate. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the quinidine gluconate profile page.
Summary for 089338
| Tradename: | QUINIDINE GLUCONATE |
| Applicant: | Sun Pharm Industries |
| Ingredient: | quinidine gluconate |
| Patents: | 0 |
Pharmacology for NDA: 089338
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors |
Suppliers and Packaging for NDA: 089338
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUINIDINE GLUCONATE | quinidine gluconate | TABLET, EXTENDED RELEASE;ORAL | 089338 | ANDA | Golden State Medical Supply | 51407-288 | 51407-288-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-288-01) |
| QUINIDINE GLUCONATE | quinidine gluconate | TABLET, EXTENDED RELEASE;ORAL | 089338 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-141 | 53489-141-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 324MG | ||||
| Approval Date: | Feb 11, 1987 | TE: | AB | RLD: | No | ||||
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