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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078009


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NDA 078009 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 078009
Tradename:LAMOTRIGINE
Applicant:Zydus Pharms Usa Inc
Ingredient:lamotrigine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078009
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE lamotrigine TABLET, FOR SUSPENSION;ORAL 078009 ANDA Zydus Lifesciences Limited 65841-689 65841-689-01 100 TABLET, CHEWABLE in 1 BOTTLE (65841-689-01)
LAMOTRIGINE lamotrigine TABLET, FOR SUSPENSION;ORAL 078009 ANDA Zydus Lifesciences Limited 65841-689 65841-689-05 500 TABLET, CHEWABLE in 1 BOTTLE (65841-689-05)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength5MG
Approval Date:Jan 22, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength25MG
Approval Date:Jan 22, 2009TE:ABRLD:No

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