Details for New Drug Application (NDA): 209465
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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 209465
Tradename: | LACOSAMIDE |
Applicant: | Zydus Pharms |
Ingredient: | lacosamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209465
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 209465
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACOSAMIDE | lacosamide | SOLUTION;INTRAVENOUS | 209465 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1359 | 70710-1359-6 | 10 VIAL in 1 CARTON (70710-1359-6) / 20 mL in 1 VIAL (70710-1359-1) |
LACOSAMIDE | lacosamide | SOLUTION;INTRAVENOUS | 209465 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1886 | 70710-1886-6 | 10 VIAL in 1 CARTON (70710-1886-6) / 20 mL in 1 VIAL (70710-1886-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/20ML (10MG/ML) | ||||
Approval Date: | Jun 29, 2022 | TE: | AP | RLD: | No |
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