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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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Dow
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Federal Trade Commission
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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079099

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NDA 079099 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 sixty-four 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. Sixty-five suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 079099
Tradename:LAMOTRIGINE
Applicant:Glenmark Pharms Ltd
Ingredient:lamotrigine
Patents:0
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079099
Suppliers and Packaging for NDA: 079099
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE lamotrigine TABLET, CHEWABLE;ORAL 079099 ANDA Glenmark Pharmaceuticals Inc., USA 68462-228 N 68462-228-01
LAMOTRIGINE lamotrigine TABLET, CHEWABLE;ORAL 079099 ANDA Glenmark Pharmaceuticals Inc., USA 68462-228 N 68462-228-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength5MG
Approval Date:Feb 19, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength25MG
Approval Date:Feb 19, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
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Harvard Business School
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Boehringer Ingelheim
Chubb
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