Details for New Drug Application (NDA): 214672
✉ Email this page to a colleague
The generic ingredient in LACOSAMIDE is lacosamide. There are twenty-two drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 214672
Tradename: | LACOSAMIDE |
Applicant: | Alkem Labs Ltd |
Ingredient: | lacosamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214672
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 214672
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACOSAMIDE | lacosamide | SOLUTION;ORAL | 214672 | ANDA | Ascend Laboratories, LLC | 67877-732 | 67877-732-95 | 200 mL in 1 BOTTLE (67877-732-95) |
LACOSAMIDE | lacosamide | SOLUTION;ORAL | 214672 | ANDA | Ascend Laboratories, LLC | 67877-732 | 67877-732-97 | 465 mL in 1 BOTTLE (67877-732-97) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
Approval Date: | May 19, 2022 | TE: | AA | RLD: | No |
Complete Access Available with Subscription