Details for New Drug Application (NDA): 210278
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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 210278
Tradename: | TOPIRAMATE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | topiramate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210278
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: 210278
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOPIRAMATE | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 210278 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-370 | 68462-370-05 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-05) |
TOPIRAMATE | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 210278 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-370 | 68462-370-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 25MG | ||||
Approval Date: | Feb 1, 2021 | TE: | AB2 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 50MG | ||||
Approval Date: | Feb 1, 2021 | TE: | AB2 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Feb 1, 2021 | TE: | AB2 | RLD: | No |
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