Details for New Drug Application (NDA): 090162
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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 090162
Tradename: | TOPIRAMATE |
Applicant: | Unichem Labs Ltd |
Ingredient: | topiramate |
Patents: | 0 |
Pharmacology for NDA: 090162
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: 090162
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOPIRAMATE | topiramate | TABLET;ORAL | 090162 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-115 | 29300-115-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-115-01) |
TOPIRAMATE | topiramate | TABLET;ORAL | 090162 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-115 | 29300-115-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-115-05) |
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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