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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Julphar
Accenture
Teva
Cantor Fitzgerald
Colorcon
Citi
Harvard Business School
Covington

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078525

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NDA 078525 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-three 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-four suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 078525
Tradename:LAMOTRIGINE
Applicant:Taro Pharm Inds
Ingredient:lamotrigine
Patents:0
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078525
Suppliers and Packaging for NDA: 078525
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE lamotrigine TABLET;ORAL 078525 NDA Rebel Distributors Corp 21695-107 E 21695-107-60
LAMOTRIGINE lamotrigine TABLET;ORAL 078525 NDA Rebel Distributors Corp 21695-227 E 21695-227-60

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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Dow

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