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Last Updated: April 8, 2025

Details for New Drug Application (NDA): 204857

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NDA 204857 describes LACOSAMIDE, which is a drug marketed by Acella, Apotex, Aspiro, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly, Hikma, Indoco, MSN, Somerset Theraps Llc, Zydus Pharms, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Medley Pharms, Novitium Pharma, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Glenmark Pharms Ltd, Hetero Labs Ltd V, Kanchan Hlthcare, Macleods Pharms Ltd, Msn Labs Pvt Ltd, Sciegen Pharms Inc, Sun Pharm, and Unichem, and is included in thirty-eight NDAs. It is available from forty-five 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. Forty-seven suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

Summary for 204857

Tradename:	LACOSAMIDE
Applicant:	Amneal Pharms
Ingredient:	lacosamide
Patents:	0

Pharmacology for NDA: 204857

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 204857

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACOSAMIDE	lacosamide	TABLET;ORAL	204857	ANDA	Amneal Pharmaceuticals of New York LLC	53746-923	53746-923-05	500 TABLET in 1 BOTTLE (53746-923-05)
LACOSAMIDE	lacosamide	TABLET;ORAL	204857	ANDA	Amneal Pharmaceuticals of New York LLC	53746-923	53746-923-60	60 TABLET in 1 BOTTLE (53746-923-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 17, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 17, 2022	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Mar 17, 2022	TE:		RLD:	No

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