Last Updated: September 24, 2026

Details for New Drug Application (NDA): 219699

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NDA 219699 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, Prod Development, Steranco Hlthcare, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Glenmark Pharms Ltd, Hetero Labs Ltd V, Macleods Pharms, Msn Labs Pvt Ltd, Sciegen Pharms, Sun Pharm, and Unichem, and is included in forty-four 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 is one drug master file entry for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

Summary for 219699

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

Pharmacology for NDA: 219699

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 219699

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACOSAMIDE	lacosamide	SOLUTION;ORAL	219699	ANDA	AvKARE	73190-103	73190-103-20	200 mL in 1 BOTTLE (73190-103-20)
LACOSAMIDE	lacosamide	SOLUTION;ORAL	219699	ANDA	Kesin Pharmaceutical Corporation	81033-427	81033-427-14	10 CUP, UNIT-DOSE in 1 CARTON (81033-427-14) / 5 mL in 1 CUP, UNIT-DOSE (81033-427-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Jun 26, 2025	TE:	AA	RLD:	No

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