Details for New Drug Application (NDA): 214672
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The generic ingredient in LACOSAMIDE is lacosamide. There are twenty-two drug master file entries for this compound. Fifty-six 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 |
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 | ||||
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