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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 214695


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NDA 214695 describes LACOSAMIDE, which is a drug marketed by Apotex, Aspiro, Fresenius Kabi Usa, Gland Pharma Ltd, 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-eight NDAs. It is available from thirty-six 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-eight suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 214695
Tradename:LACOSAMIDE
Applicant:Alkem Labs Ltd
Ingredient:lacosamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 214695
Suppliers and Packaging for NDA: 214695
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LACOSAMIDE lacosamide TABLET;ORAL 214695 ANDA Major Pharmaceuticals 0904-7244 0904-7244-68 60 BLISTER PACK in 1 CARTON (0904-7244-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK
LACOSAMIDE lacosamide TABLET;ORAL 214695 ANDA Major Pharmaceuticals 0904-7245 0904-7245-68 60 BLISTER PACK in 1 CARTON (0904-7245-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 31, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Mar 31, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Mar 31, 2022TE:ABRLD:No

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