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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Cantor Fitzgerald
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QuintilesIMS

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202498

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NDA 202498 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 202498
Tradename:LAMOTRIGINE
Applicant:Wockhardt Ltd
Ingredient:lamotrigine
Patents:0
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202498
Suppliers and Packaging for NDA: 202498
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 202498 ANDA Wockhardt Limited 55648-271 55648-271-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55648-271-01)
LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 202498 ANDA Wockhardt Limited 55648-271 55648-271-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55648-271-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG
Approval Date:Jan 4, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG
Approval Date:Jan 4, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Jan 4, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
Deloitte
Baxter
Medtronic
Express Scripts
Argus Health
Cipla
McKesson

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