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Last Updated: April 12, 2025

Details for New Drug Application (NDA): 206355

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NDA 206355 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-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. Forty-eight suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

Summary for 206355

Tradename:	LACOSAMIDE
Applicant:	Apotex
Ingredient:	lacosamide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Sep 26, 2022	TE:		RLD:	No

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