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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 215628

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NDA 215628 describes LACOSAMIDE, which is a drug marketed by Acella, Apotex, Aspiro, Dr Reddys, Fresenius Kabi Usa, Gland, 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, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Glenmark Pharms Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Msn Labs Pvt Ltd, Sciegen Pharms Inc, Sun Pharm, and Unichem, and is included in forty NDAs. It is available from fifty-four 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-six suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

Summary for 215628

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

Pharmacology for NDA: 215628

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 215628

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACOSAMIDE	lacosamide	SOLUTION;INTRAVENOUS	215628	ANDA	Gland Pharma Limited	68083-480	68083-480-10	10 VIAL, SINGLE-DOSE in 1 CARTON (68083-480-10) / 20 mL in 1 VIAL, SINGLE-DOSE
LACOSAMIDE	lacosamide	SOLUTION;INTRAVENOUS	215628	ANDA	Virtus Pharmaceuticals, LLC	69543-455	69543-455-10	10 VIAL, GLASS in 1 CARTON (69543-455-10) / 20 mL in 1 VIAL, GLASS (69543-455-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	200MG/20ML (10MG/ML)
Approval Date:	Sep 19, 2022	TE:	AP	RLD:	No

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