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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 214695

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NDA 214695 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 214695

Tradename:	LACOSAMIDE
Applicant:	Alkem Labs Ltd
Ingredient:	lacosamide
Patents:	0

Pharmacology for NDA: 214695

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 214695

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACOSAMIDE	lacosamide	TABLET;ORAL	214695	ANDA	Major Pharmaceuticals	0904-7244	0904-7244-68	60 BLISTER PACK in 1 CARTON (0904-7244-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK
LACOSAMIDE	lacosamide	TABLET;ORAL	214695	ANDA	Major Pharmaceuticals	0904-7245	0904-7245-68	60 BLISTER PACK in 1 CARTON (0904-7245-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 31, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 31, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Mar 31, 2022	TE:	AB	RLD:	No

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