Details for New Drug Application (NDA): 076575
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The generic ingredient in TOPIRAMATE is topiramate. There are twenty-six drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 076575
Tradename: | TOPIRAMATE |
Applicant: | Teva |
Ingredient: | topiramate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076575
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: 076575
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOPIRAMATE | topiramate | CAPSULE;ORAL | 076575 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7335 | 0093-7335-06 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0093-7335-06) |
TOPIRAMATE | topiramate | CAPSULE;ORAL | 076575 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7336 | 0093-7336-06 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0093-7336-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
Approval Date: | Apr 17, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Apr 17, 2009 | TE: | AB | RLD: | No |
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