Last Updated: May 11, 2026

Details for New Drug Application (NDA): 078009

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NDA 078009 describes LAMOTRIGINE, which is a drug marketed by Actavis Elizabeth, Alembic, Amneal Pharms, Dr Reddys Labs Ltd, Ph Health, Rubicon Research, Sciegen Pharms, Torrent, Yiling, Zydus Pharms, Aurobindo Pharma, Chartwell Rx, Glenmark Pharms Ltd, Jubilant Generics, Pharmobedient, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Actavis Totowa, Aiping Pharm Inc, Alembic Pharms Ltd, Alkem Labs Ltd, Chartwell Molecular, Granules, Hikma Pharms, Ipca Labs, Jubilant Cadista, Lupin Ltd, Natco Pharma, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa, and is included in fifty-four NDAs. It is available from forty-nine suppliers. Additional details are available on the LAMOTRIGINE profile page.

The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

Summary for 078009

Tradename:	LAMOTRIGINE
Applicant:	Zydus Pharms Usa Inc
Ingredient:	lamotrigine
Patents:	0

Pharmacology for NDA: 078009

Mechanism of Action	Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 078009

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMOTRIGINE	lamotrigine	TABLET, FOR SUSPENSION;ORAL	078009	ANDA	Zydus Lifesciences Limited	65841-689	65841-689-01	100 TABLET, CHEWABLE in 1 BOTTLE (65841-689-01)
LAMOTRIGINE	lamotrigine	TABLET, FOR SUSPENSION;ORAL	078009	ANDA	Zydus Lifesciences Limited	65841-689	65841-689-05	500 TABLET, CHEWABLE in 1 BOTTLE (65841-689-05)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	5MG
Approval Date:	Jan 22, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	25MG
Approval Date:	Jan 22, 2009	TE:	AB	RLD:	No

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