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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 218014

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NDA 218014 describes LACOSAMIDE, which is a drug marketed by Acella, Anthea Pharma, 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, Sun Pharm, and Unichem, and is included in forty-two NDAs. It is available from fifty-three 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-five suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

Summary for 218014

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

Pharmacology for NDA: 218014

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 218014

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACOSAMIDE	lacosamide	TABLET;ORAL	218014	ANDA	Marlex Pharmaceuticals, Inc	10135-799	10135-799-60	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-799-60)
LACOSAMIDE	lacosamide	TABLET;ORAL	218014	ANDA	Marlex Pharmaceuticals, Inc	10135-799	10135-799-86	6 BLISTER PACK in 1 CARTON (10135-799-86) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Apr 2, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Apr 2, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Apr 2, 2024	TE:	AB	RLD:	No

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