Details for New Drug Application (NDA): 216151
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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 216151
Tradename: | LACOSAMIDE |
Applicant: | Novitium Pharma |
Ingredient: | lacosamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216151
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 216151
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACOSAMIDE | lacosamide | SOLUTION;ORAL | 216151 | ANDA | PAI Holdings, LLC | 0121-1012 | 0121-1012-95 | 1 TRAY in 1 CASE (0121-1012-95) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1012-05) |
LACOSAMIDE | lacosamide | SOLUTION;ORAL | 216151 | ANDA | PAI Holdings, LLC | 0121-2024 | 0121-2024-95 | 1 TRAY in 1 TRAY (0121-2024-95) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-2024-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
Approval Date: | Aug 26, 2022 | TE: | AA | RLD: | No |
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