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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 078625

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NDA 078625 describes LAMOTRIGINE, which is a drug marketed by Actavis Elizabeth, Alembic, Amneal Pharms, Dr Reddys Labs Ltd, Endo Operations, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Norvium Bioscience, 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, 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-one NDAs. It is available from fifty-two 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-three suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

Summary for 078625

Tradename:	LAMOTRIGINE
Applicant:	Rubicon
Ingredient:	lamotrigine
Patents:	0

Pharmacology for NDA: 078625

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: 078625

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMOTRIGINE	lamotrigine	TABLET;ORAL	078625	ANDA	REMEDYREPACK INC.	70518-3602	70518-3602-0	30 TABLET in 1 BLISTER PACK (70518-3602-0)
LAMOTRIGINE	lamotrigine	TABLET;ORAL	078625	ANDA	REMEDYREPACK INC.	70518-3602	70518-3602-1	90 TABLET in 1 BOTTLE, PLASTIC (70518-3602-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jan 27, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jan 27, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Jan 27, 2009	TE:	AB	RLD:	No

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