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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215979

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NDA 215979 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 215979

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

Pharmacology for NDA: 215979

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 215979

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACOSAMIDE	lacosamide	SOLUTION;INTRAVENOUS	215979	ANDA	Novadoz Pharmaceuticals LLC	72205-220	72205-220-07	10 VIAL in 1 CARTON (72205-220-07) / 20 mL in 1 VIAL (72205-220-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	200MG/20ML (10MG/ML)
Approval Date:	Feb 9, 2023	TE:	AP	RLD:	No

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