DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 076327
The generic ingredient in TOPIRAMATE is topiramate. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 076327
Tradename: | TOPIRAMATE |
Applicant: | Sun Pharm Inds Ltd |
Ingredient: | topiramate |
Patents: | 0 |
Therapeutic Class: | Anticonvulsants Antimigraine Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076327
Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 076327
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOPIRAMATE | topiramate | TABLET;ORAL | 076327 | ANDA | Ranbaxy Pharmaceuticals Inc | 63304-778 | N | 63304-778-10 |
TOPIRAMATE | topiramate | TABLET;ORAL | 076327 | ANDA | Ranbaxy Pharmaceuticals Inc | 63304-778 | N | 63304-778-30 |
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 | 100MG | ||||
Approval Date: | Mar 27, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Mar 27, 2009 | TE: | AB | RLD: | No |
Complete Access Available with Subscription