BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Cipla
QuintilesIMS
Argus Health
Covington
US Army
Federal Trade Commission
Harvard Business School
Deloitte
US Department of Justice

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076708

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NDA 076708 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-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. Sixty-seven suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 076708
Tradename:LAMOTRIGINE
Applicant:Dr Reddys Labs Ltd
Ingredient:lamotrigine
Patents:0
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076708
Suppliers and Packaging for NDA: 076708
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE lamotrigine TABLET;ORAL 076708 ANDA Dr.Reddy's Laboratories Limited 55111-220 55111-220-30 30 TABLET in 1 BOTTLE (55111-220-30)
LAMOTRIGINE lamotrigine TABLET;ORAL 076708 ANDA Dr.Reddy's Laboratories Limited 55111-220 55111-220-78 10 BLISTER PACK in 1 CARTON (55111-220-78) > 10 TABLET in 1 BLISTER PACK (55111-220-79)

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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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Medtronic
Healthtrust
Moodys
Cerilliant
Novartis
AstraZeneca
Teva
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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