Last Updated: August 3, 2026

Details for New Drug Application (NDA): 220366

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NDA 220366 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, 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-three 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 220366

Tradename:	LACOSAMIDE
Applicant:	Steranco Hlthcare
Ingredient:	lacosamide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	May 21, 2026	TE:	AA	RLD:	No

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