Details for New Drug Application (NDA): 077869
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NDA 077869 describes ZONISAMIDE, which is a drug marketed by Ani Pharms, Apotex, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Epic Pharma Llc, Glenmark Pharms Inc, Granules, Invagen Pharms, Macleods Pharms Ltd, Pharmobedient, Rising, Roxane, Sun Pharm Inds (in), Sun Pharm Industries, Unichem, Upsher Smith Labs, and Zydus Lifesciences, and is included in nineteen NDAs. It is available from twenty 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-two 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-two suppliers are listed for this compound. Additional details are available on the zonisamide profile page.
Summary for 077869
| Tradename: | ZONISAMIDE |
| Applicant: | Invagen Pharms |
| Ingredient: | zonisamide |
| Patents: | 0 |
Pharmacology for NDA: 077869
| Mechanism of Action | Carbonic Anhydrase Inhibitors P-Glycoprotein Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 077869
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZONISAMIDE | zonisamide | CAPSULE;ORAL | 077869 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8266 | 0615-8266-39 | 30 CAPSULE in 1 BLISTER PACK (0615-8266-39) |
| ZONISAMIDE | zonisamide | CAPSULE;ORAL | 077869 | ANDA | AvPAK | 50268-816 | 50268-816-15 | 50 BLISTER PACK in 1 BOX (50268-816-15) / 1 CAPSULE in 1 BLISTER PACK (50268-816-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | May 31, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | May 31, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | May 31, 2006 | TE: | AB | RLD: | No | ||||
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