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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078956


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NDA 078956 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 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 078956
Tradename:LAMOTRIGINE
Applicant:Aurobindo Pharma
Ingredient:lamotrigine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078956
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE lamotrigine TABLET;ORAL 078956 ANDA NorthStar Rx LLC 16714-700 16714-700-01 100 TABLET in 1 BOTTLE (16714-700-01)
LAMOTRIGINE lamotrigine TABLET;ORAL 078956 ANDA NorthStar Rx LLC 16714-701 16714-701-01 100 TABLET in 1 BOTTLE (16714-701-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jan 27, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 27, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 27, 2009TE:ABRLD:No

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