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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 217311

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NDA 217311 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 217311

Tradename:	LACOSAMIDE
Applicant:	Hainan Poly
Ingredient:	lacosamide
Patents:	0

Pharmacology for NDA: 217311

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 217311

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACOSAMIDE	lacosamide	SOLUTION;INTRAVENOUS	217311	ANDA	Hainan Poly Pharm. Co., Ltd.	14335-330	14335-330-10	10 VIAL, GLASS in 1 CARTON (14335-330-10) / 20 mL in 1 VIAL, GLASS
LACOSAMIDE	lacosamide	SOLUTION;INTRAVENOUS	217311	ANDA	Sintetica US LLC	83090-012	83090-012-10	10 VIAL, GLASS in 1 CARTON (83090-012-10) / 20 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	200MG/20ML (10MG/ML)
Approval Date:	Feb 13, 2024	TE:	AP	RLD:	No

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