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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 200672

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NDA 200672 describes LAMOTRIGINE, which is a drug marketed by Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Dr Reddys Labs Ltd, Par Pharm, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alembic Pharms Ltd, Alkem Labs Ltd, Chartwell Molecular, Glenmark Generics, Granules, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa, and is included in forty-nine NDAs. It is available from fifty-one 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-two suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

Summary for 200672

Tradename:	LAMOTRIGINE
Applicant:	Actavis Elizabeth
Ingredient:	lamotrigine
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 200672

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: 200672

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	200672	ANDA	Actavis Pharma, Inc.	0228-1410	0228-1410-03	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1410-03)
LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	200672	ANDA	Actavis Pharma, Inc.	0228-1422	0228-1422-03	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1422-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	25MG
Approval Date:	Oct 17, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Oct 17, 2013	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Oct 17, 2013	TE:	AB	RLD:	No

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