Details for New Drug Application (NDA): 214679
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NDA 214679 describes EPRONTIA, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the EPRONTIA profile page.
The generic ingredient in EPRONTIA is topiramate. There are twenty-six drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the topiramate profile page.
The generic ingredient in EPRONTIA is topiramate. There are twenty-six drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 214679
| Tradename: | EPRONTIA |
| Applicant: | Azurity |
| Ingredient: | topiramate |
| Patents: | 5 |
Pharmacology for NDA: 214679
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 214679
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPRONTIA | topiramate | SOLUTION;ORAL | 214679 | NDA | Azurity Pharmaceuticals, Inc. | 52652-9001 | 52652-9001-1 | 473 mL in 1 BOTTLE (52652-9001-1) |
| EPRONTIA | topiramate | SOLUTION;ORAL | 214679 | NDA | Azurity Pharmaceuticals, Inc. | 52652-9001 | 52652-9001-2 | 1 BOTTLE in 1 CARTON (52652-9001-2) / 240 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 25MG/ML | ||||
| Approval Date: | Nov 5, 2021 | TE: | AB | RLD: | Yes | ||||
| Patent: | 11,433,046 | Patent Expiration: | Aug 21, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | INDICATED AS ADJUNCTIVE THERAPY FOR THE TREATMENT OF PARTIAL-ONSET SEIZURES, PRIMARY GENERALIZED TONIC-CLONIC SEIZURES, AND SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 11,433,046 | Patent Expiration: | Aug 21, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | INDICATED AS INITIAL MONOTHERAPY FOR THE TREATMENT OF PARTIAL-ONSET OR PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 2 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 11,433,046 | Patent Expiration: | Aug 21, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | INDICATED FOR THE PREVENTIVE TREATMENT OF MIGRAINE IN PATIENTS 12 YEARS AND OLDER | ||||||||
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