Details for New Drug Application (NDA): 214695
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The generic ingredient in LACOSAMIDE is lacosamide. There are twenty-two drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 214695
Tradename: | LACOSAMIDE |
Applicant: | Alkem Labs Ltd |
Ingredient: | lacosamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214695
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 214695
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACOSAMIDE | lacosamide | TABLET;ORAL | 214695 | ANDA | Major Pharmaceuticals | 0904-7244 | 0904-7244-68 | 60 BLISTER PACK in 1 CARTON (0904-7244-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
LACOSAMIDE | lacosamide | TABLET;ORAL | 214695 | ANDA | Major Pharmaceuticals | 0904-7245 | 0904-7245-68 | 60 BLISTER PACK in 1 CARTON (0904-7245-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 31, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Mar 31, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Mar 31, 2022 | TE: | AB | RLD: | No |
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