Last Updated: November 8, 2026

Details for New Drug Application (NDA): 207497

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NDA 207497 describes LAMOTRIGINE, which is a drug marketed by Actavis Elizabeth, Alembic, Amneal Pharms, Dr Reddys Labs Ltd, Ph Health, Pharmobedient, Rubicon Research, Sciegen Pharms, Torrent, Zydus Pharms, Aurobindo Pharma, Chartwell Rx, Glenmark Pharms Ltd, Jubilant Generics, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Impax Labs Inc, J Molner, 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 is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

Summary for 207497

Tradename:	LAMOTRIGINE
Applicant:	Amneal Pharms
Ingredient:	lamotrigine
Patents:	0

Pharmacology for NDA: 207497

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: 207497

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	207497	ANDA	AvKARE	42291-443	42291-443-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-443-30)
LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	207497	ANDA	AvKARE	42291-444	42291-444-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-444-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	25MG
Approval Date:	Nov 30, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Nov 30, 2018	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Nov 30, 2018	TE:	AB	RLD:	No

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