Details for New Drug Application (NDA): 077645
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NDA 077645 describes ZONISAMIDE, which is a drug marketed by Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bionpharma, Epic Pharma Llc, Glenmark Pharms Inc, Granules, Heritage Pharma Avet, Invagen Pharms, Norvium Bioscience, Rising, Roxane, Sun Pharm Inds (in), Sun Pharm Industries, Unichem, Upsher Smith Labs, and Zydus Lifesciences, and is included in eighteen NDAs. It is available from eighteen suppliers. Additional details are available on the ZONISAMIDE profile page.
The generic ingredient in ZONISAMIDE is zonisamide. There are nineteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the zonisamide profile page.
The generic ingredient in ZONISAMIDE is zonisamide. There are nineteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the zonisamide profile page.
Summary for 077645
| Tradename: | ZONISAMIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | zonisamide |
| Patents: | 0 |
Pharmacology for NDA: 077645
| Mechanism of Action | Carbonic Anhydrase Inhibitors P-Glycoprotein Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 077645
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZONISAMIDE | zonisamide | CAPSULE;ORAL | 077645 | ANDA | Aurobindo Pharma Limited | 59651-378 | 59651-378-01 | 100 CAPSULE in 1 BOTTLE (59651-378-01) |
| ZONISAMIDE | zonisamide | CAPSULE;ORAL | 077645 | ANDA | Aurobindo Pharma Limited | 59651-378 | 59651-378-03 | 30 CAPSULE in 1 BOTTLE (59651-378-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 22, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Sep 29, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Sep 29, 2006 | TE: | AB | RLD: | No | ||||
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