Last Updated: November 13, 2026

Details for New Drug Application (NDA): 215379

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NDA 215379 describes LACOSAMIDE, which is a drug marketed by Acella, Apotex, Aspiro, Dr Reddys, Fresenius Kabi Usa, Gland, Glenmark Pharms, Hainan Poly, Hikma, MSN, Op Nanopharma, Regcon Holdings, Somerset Theraps Llc, Zydus Pharms, Adaptis, Ajenat Pharms, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Novitium Pharma, Pharmazone, Prod Development, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Glenmark Pharms Ltd, Hetero Labs Ltd V, Macleods Pharms, Msn Labs Pvt Ltd, Sciegen Pharms, Sun Pharm, and Unichem, and is included in forty-four NDAs. It is available from fifty-seven suppliers. Additional details are available on the LACOSAMIDE profile page.

The generic ingredient in LACOSAMIDE is lacosamide. There is one drug master file entry for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

Summary for 215379

Tradename:	LACOSAMIDE
Applicant:	Msn
Ingredient:	lacosamide
Patents:	0

Pharmacology for NDA: 215379

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 215379

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACOSAMIDE	lacosamide	SOLUTION;ORAL	215379	ANDA	Glenmark Pharmaceuticals Limited	68462-940	68462-940-86	200 mL in 1 BOTTLE, PLASTIC (68462-940-86)
LACOSAMIDE	lacosamide	SOLUTION;ORAL	215379	ANDA	Bryant Ranch Prepack	72162-2637	72162-2637-2	200 mL in 1 BOTTLE, PLASTIC (72162-2637-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Dec 22, 2023	TE:	AA	RLD:	No

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