Last Updated: July 27, 2026

Details for New Drug Application (NDA): 209224

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NDA 209224 describes LACOSAMIDE, which is a drug marketed by Acella, Apotex, Aspiro, Dr Reddys, Fresenius Kabi Usa, Gland, Glenmark Pharms, 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, Steranco Hlthcare, 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-three NDAs. It is available from fifty-six 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-eight suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

Summary for 209224

Tradename:	LACOSAMIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	lacosamide
Patents:	0

Pharmacology for NDA: 209224

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 209224

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACOSAMIDE	lacosamide	SOLUTION;ORAL	209224	ANDA	Aurobindo Pharma Limited	59651-016	59651-016-02	200 mL in 1 BOTTLE, PLASTIC (59651-016-02)
LACOSAMIDE	lacosamide	SOLUTION;ORAL	209224	ANDA	Aurobindo Pharma Limited	59651-016	59651-016-46	465 mL in 1 BOTTLE, PLASTIC (59651-016-46)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Jan 24, 2024	TE:	AA	RLD:	No

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