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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 216461

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NDA 216461 describes LACOSAMIDE, which is a drug marketed by 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, Leading Pharma, 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-seven NDAs. It is available from forty-five 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-seven suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

Summary for 216461

Tradename:	LACOSAMIDE
Applicant:	Leading Pharma
Ingredient:	lacosamide
Patents:	0

Pharmacology for NDA: 216461

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 216461

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACOSAMIDE	lacosamide	SOLUTION;ORAL	216461	ANDA	Leading Pharma, LLC	69315-318	69315-318-20	200 mL in 1 BOTTLE, PLASTIC (69315-318-20)
LACOSAMIDE	lacosamide	SOLUTION;ORAL	216461	ANDA	Leading Pharma, LLC	69315-318	69315-318-46	465 mL in 1 BOTTLE, PLASTIC (69315-318-46)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Feb 6, 2023	TE:	AA	RLD:	No

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