Details for New Drug Application (NDA): 214273
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The generic ingredient in ZONISADE 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 214273
| Tradename: | ZONISADE |
| Applicant: | Azurity |
| Ingredient: | zonisamide |
| Patents: | 3 |
Pharmacology for NDA: 214273
| Mechanism of Action | Carbonic Anhydrase Inhibitors P-Glycoprotein Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 214273
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZONISADE | zonisamide | SUSPENSION;ORAL | 214273 | NDA | Azurity Pharmaceuticals, Inc. | 52652-8001 | 52652-8001-1 | 1 BOTTLE in 1 CARTON (52652-8001-1) / 150 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 100MG/5ML | ||||
| Approval Date: | Jul 15, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 18, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING SEIZURES | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 18, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 18, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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