Details for New Drug Application (NDA): 079162
✉ Email this page to a colleague
The generic ingredient in TOPIRAMATE is topiramate. There are twenty-six drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 079162
Tradename: | TOPIRAMATE |
Applicant: | Invagen Pharms |
Ingredient: | topiramate |
Patents: | 0 |
Pharmacology for NDA: 079162
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: 079162
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOPIRAMATE | topiramate | TABLET;ORAL | 079162 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-695 | 43353-695-60 | 90 TABLET in 1 BOTTLE (43353-695-60) |
TOPIRAMATE | topiramate | TABLET;ORAL | 079162 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-695 | 43353-695-80 | 180 TABLET in 1 BOTTLE (43353-695-80) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Mar 27, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 27, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Mar 27, 2009 | TE: | AB | RLD: | No |
Complete Access Available with Subscription