Details for New Drug Application (NDA): 214273
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NDA 214273 describes ZONISADE, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ZONISADE profile page.
The generic ingredient in ZONISADE 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 ZONISADE 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 214273
| Tradename: | ZONISADE |
| Applicant: | Azurity |
| Ingredient: | zonisamide |
| Patents: | 2 |
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 Phramaceuticals, 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: | ⤷ Sign Up | Patent Expiration: | Aug 18, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING SEIZURES | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 18, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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