Details for New Drug Application (NDA): 215628
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The generic ingredient in LACOSAMIDE is lacosamide. There are twenty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 215628
Tradename: | LACOSAMIDE |
Applicant: | Gland Pharma Ltd |
Ingredient: | lacosamide |
Patents: | 0 |
Pharmacology for NDA: 215628
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 215628
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACOSAMIDE | lacosamide | SOLUTION;INTRAVENOUS | 215628 | ANDA | Gland Pharma Limited | 68083-480 | 68083-480-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-480-10) / 20 mL in 1 VIAL, SINGLE-DOSE |
LACOSAMIDE | lacosamide | SOLUTION;INTRAVENOUS | 215628 | ANDA | Virtus Pharmaceuticals, LLC | 69543-455 | 69543-455-10 | 10 VIAL, GLASS in 1 CARTON (69543-455-10) / 20 mL in 1 VIAL, GLASS (69543-455-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/20ML (10MG/ML) | ||||
Approval Date: | Sep 19, 2022 | TE: | AP | RLD: | No |
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