Details for New Drug Application (NDA): 207382
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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 207382
Tradename: | TOPIRAMATE |
Applicant: | Zydus |
Ingredient: | topiramate |
Patents: | 0 |
Pharmacology for NDA: 207382
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: 207382
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOPIRAMATE | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 207382 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-358 | 68382-358-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-01) |
TOPIRAMATE | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 207382 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-358 | 68382-358-05 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 25MG | ||||
Approval Date: | Nov 24, 2017 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 50MG | ||||
Approval Date: | Nov 24, 2017 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Nov 24, 2017 | TE: | AB1 | RLD: | No |
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