Last Updated: August 8, 2026

Details for New Drug Application (NDA): 214960

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NDA 214960 describes LACOSAMIDE, which is a drug marketed by Acella, Apotex, Aspiro, Dr Reddys, Fresenius Kabi Usa, Gland, Glenmark Pharms, Hainan Poly, Hikma, MSN, Regcon Holdings, Somerset Theraps Llc, Westminster Pharms, Zydus Pharms, Ajenat Pharms, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Kanchan Hlthcare, Novitium Pharma, Prod Development, Steranco Hlthcare, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Glenmark Pharms Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Msn Labs Pvt Ltd, Sciegen Pharms, Sun Pharm, and Unichem, and is included in forty-four NDAs. It is available from fifty-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. Fifty-eight suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

Summary for 214960

Tradename:	LACOSAMIDE
Applicant:	Somerset Theraps Llc
Ingredient:	lacosamide
Patents:	0

Pharmacology for NDA: 214960

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 214960

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACOSAMIDE	lacosamide	SOLUTION;INTRAVENOUS	214960	ANDA	Somerset Therapeutics, LLC	70069-471	70069-471-10	10 VIAL, SINGLE-DOSE in 1 CARTON (70069-471-10) / 20 mL in 1 VIAL, SINGLE-DOSE (70069-471-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	200MG/20ML (10MG/ML)
Approval Date:	Oct 9, 2024	TE:	AP	RLD:	No

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