Details for New Drug Application (NDA): 214301
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NDA 214301 describes LACOSAMIDE, which is a drug marketed by Apotex, Aspiro, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly, Indoco, MSN, Zydus Pharms, Alkem Labs Ltd, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Leading Pharma, Novitium Pharma, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Amneal Pharms, Glenmark Pharms Ltd, Hetero Labs Ltd V, Msn Labs Pvt Ltd, Sciegen Pharms Inc, and Sun Pharm, and is included in twenty-nine NDAs. It is available from thirty-seven suppliers. Additional details are available on the LACOSAMIDE profile page.
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.
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 214301
| Tradename: | LACOSAMIDE |
| Applicant: | Indoco |
| Ingredient: | lacosamide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214301
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 214301
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LACOSAMIDE | lacosamide | SOLUTION;INTRAVENOUS | 214301 | ANDA | Indoco Remedies Limited | 14445-406 | 14445-406-20 | 10 VIAL, GLASS in 1 CARTON (14445-406-20) / 20 mL in 1 VIAL, GLASS |
| LACOSAMIDE | lacosamide | SOLUTION;INTRAVENOUS | 214301 | ANDA | Sagent Pharmaceuticals | 25021-791 | 25021-791-20 | 10 VIAL, GLASS in 1 CARTON (25021-791-20) / 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: | Apr 7, 2022 | TE: | AP | RLD: | No | ||||
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