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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
McKinsey
McKesson
Accenture
Johnson and Johnson
Farmers Insurance
Merck
Medtronic
UBS

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078134

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NDA 078134 describes LAMOTRIGINE, which is a drug marketed by Alembic Pharms Ltd, Aurobindo Pharma, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Actavis Elizabeth, Anchen Pharms, Handa Pharms Llc, Par Pharm, Torrent Pharms Ltd, Wockhardt Ltd, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Apotex Inc, Cipla Ltd, Glenmark Generics, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Pharmascience Inc, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Wockhardt, and Zydus Pharms Usa, and is included in forty-five NDAs. It is available from fifty-six 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-seven suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 078134
Tradename:LAMOTRIGINE
Applicant:Hikma Pharms
Ingredient:lamotrigine
Patents:0
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Apr 19, 2011TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Apr 19, 2011TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength150MG
Approval Date:Apr 19, 2011TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Mallinckrodt
Queensland Health
Moodys
US Department of Justice
Express Scripts
Harvard Business School
Johnson and Johnson
Teva

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