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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 200828

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NDA 200828 describes LAMOTRIGINE, which is a drug marketed by Actavis Elizabeth, Alembic, Amneal Pharms, Dr Reddys Labs Ltd, Ph Health, Rubicon Research, Sciegen Pharms Inc, 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-two NDAs. It is available from fifty 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-one suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

Summary for 200828

Tradename:	LAMOTRIGINE
Applicant:	Impax Labs Inc
Ingredient:	lamotrigine
Patents:	0

Pharmacology for NDA: 200828

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: 200828

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMOTRIGINE	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	200828	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1526	0115-1526-08	2 BLISTER PACK in 1 CARTON (0115-1526-08) / 15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1526-68)
LAMOTRIGINE	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	200828	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1527	0115-1527-08	2 BLISTER PACK in 1 CARTON (0115-1527-08) / 15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1527-68)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	25MG
Approval Date:	Jul 15, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	50MG
Approval Date:	Jul 15, 2013	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	100MG
Approval Date:	Jul 15, 2013	TE:	AB	RLD:	No

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