Details for New Drug Application (NDA): 078462
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The generic ingredient in TOPIRAMATE is topiramate. There are twenty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 078462
Tradename: | TOPIRAMATE |
Applicant: | Aurobindo Pharma |
Ingredient: | topiramate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078462
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: 078462
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOPIRAMATE | topiramate | TABLET;ORAL | 078462 | ANDA | Rising Pharma Holdings, Inc. | 16571-705 | 16571-705-06 | 60 TABLET, FILM COATED in 1 BOTTLE (16571-705-06) |
TOPIRAMATE | topiramate | TABLET;ORAL | 078462 | ANDA | Rising Pharma Holdings, Inc. | 16571-705 | 16571-705-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (16571-705-10) |
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 |
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