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Serving leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
McKesson
Fuji
Dow
Medtronic
Colorcon
Teva
Cerilliant
Citi

Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200828

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NDA 200828 describes LAMOTRIGINE, which is a drug marketed by Aurobindo Pharma, Dr Reddys Labs Ltd, Taro, Alembic Pharms Ltd, Sandoz, Zydus Pharms Usa Inc, Pharmascience Inc, Jubilant Generics, Teva, Mylan, Apotex Inc, Taro Pharm Inds, Watson Labs, Impax Labs Inc, Jubilant Cadista, Actavis Elizabeth, Zydus Pharms Usa, Hikma Pharms, Mylan Labs Ltd, Torrent Pharms, Par Pharm, Actavis Totowa, Glenmark Generics, Torrent Pharms Ltd, Unichem Labs Ltd, Anchen Pharms, Sciegen Pharms Inc, Wockhardt, Cipla Ltd, Handa Pharms Llc, Lupin Ltd, Roxane, Alkem Labs Ltd, Wockhardt Ltd, and Glenmark Pharms Ltd, 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 200828

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 200828

Suppliers and Packaging for NDA: 200828

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE
lamotrigine
TABLET, ORALLY DISINTEGRATING;ORAL 200828 ANDA Impax Generics 0115-1526 0115-1526-08 2 BLISTER PACK in 1 CARTON (0115-1526-08) > 15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1526-68)
LAMOTRIGINE
lamotrigine
TABLET, ORALLY DISINTEGRATING;ORAL 200828 ANDA Impax Generics 0115-1527 0115-1527-08 2 BLISTER PACK in 1 CARTON (0115-1527-08) > 15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1527-68)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG
Approval Date:Jul 15, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength50MG
Approval Date:Jul 15, 2013TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength100MG
Approval Date:Jul 15, 2013TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Julphar
Accenture
Dow
Chubb
Johnson and Johnson
Federal Trade Commission
Cerilliant
US Department of Justice
Deloitte

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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