Last Updated: May 10, 2026

Details for New Drug Application (NDA): 220386

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NDA 220386 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, 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-two 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 220386

Tradename:	LACOSAMIDE
Applicant:	Regcon Holdings
Ingredient:	lacosamide
Patents:	0

Pharmacology for NDA: 220386

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 220386

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACOSAMIDE	lacosamide	SOLUTION;ORAL	220386	ANDA	Florida Pharmaceutical Products, LLC	71921-411	71921-411-71	1 BOTTLE in 1 CARTON (71921-411-71) / 200 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Jan 29, 2026	TE:	AA	RLD:	No

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