Details for New Drug Application (NDA): 214492
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The generic ingredient in ZONISAMIDE is zonisamide. There are nineteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the zonisamide profile page.
Summary for 214492
Tradename: | ZONISAMIDE |
Applicant: | Unichem |
Ingredient: | zonisamide |
Patents: | 0 |
Pharmacology for NDA: 214492
Mechanism of Action | Carbonic Anhydrase Inhibitors P-Glycoprotein Inhibitors |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 214492
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZONISAMIDE | zonisamide | CAPSULE;ORAL | 214492 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-428 | 29300-428-01 | 100 CAPSULE in 1 BOTTLE (29300-428-01) |
ZONISAMIDE | zonisamide | CAPSULE;ORAL | 214492 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-428 | 29300-428-05 | 500 CAPSULE in 1 BOTTLE (29300-428-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Jan 26, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Jan 26, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Jan 26, 2021 | TE: | AB | RLD: | No |
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