Details for New Drug Application (NDA): 218482
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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 218482
Tradename: | TOPIRAMATE |
Applicant: | Alkem Labs Ltd |
Ingredient: | topiramate |
Patents: | 0 |
Pharmacology for NDA: 218482
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: 218482
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOPIRAMATE | topiramate | CAPSULE;ORAL | 218482 | ANDA | Ascend Laboratories, LLC | 67877-868 | 67877-868-05 | 500 CAPSULE in 1 BOTTLE (67877-868-05) |
TOPIRAMATE | topiramate | CAPSULE;ORAL | 218482 | ANDA | Ascend Laboratories, LLC | 67877-868 | 67877-868-33 | 1 BLISTER PACK in 1 CARTON (67877-868-33) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
Approval Date: | Jun 13, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Jun 13, 2024 | TE: | AB | RLD: | No |
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