Last Updated: September 24, 2026

Details for New Drug Application (NDA): 204158

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NDA 204158 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, 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 204158

Tradename:	LAMOTRIGINE
Applicant:	Ph Health
Ingredient:	lamotrigine
Patents:	0

Pharmacology for NDA: 204158

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: 204158

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMOTRIGINE	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	204158	ANDA	Par Health USA, LLC	49884-484	49884-484-11	30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (49884-484-11)
LAMOTRIGINE	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	204158	ANDA	Par Health USA, LLC	49884-485	49884-485-11	30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (49884-485-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	25MG
Approval Date:	Oct 27, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	50MG
Approval Date:	Oct 27, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	100MG
Approval Date:	Oct 27, 2015	TE:	AB	RLD:	No

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