Details for New Drug Application (NDA): 217311
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The generic ingredient in LACOSAMIDE is lacosamide. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 217311
Tradename: | LACOSAMIDE |
Applicant: | Hainan Poly |
Ingredient: | lacosamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 217311
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 217311
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACOSAMIDE | lacosamide | SOLUTION;INTRAVENOUS | 217311 | ANDA | Hainan Poly Pharm. Co., Ltd. | 14335-330 | 14335-330-10 | 10 VIAL, GLASS in 1 CARTON (14335-330-10) / 20 mL in 1 VIAL, GLASS |
LACOSAMIDE | lacosamide | SOLUTION;INTRAVENOUS | 217311 | ANDA | Sintetica US LLC | 83090-012 | 83090-012-10 | 10 VIAL, GLASS in 1 CARTON (83090-012-10) / 20 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/20ML (10MG/ML) | ||||
Approval Date: | Feb 13, 2024 | TE: | AP | RLD: | No |
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