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Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
QuintilesIMS
Mallinckrodt
Healthtrust
Johnson and Johnson
Covington
Colorcon
Deloitte
Accenture

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078134

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NDA 078134 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 078134
Tradename:LAMOTRIGINE
Applicant:Hikma Pharms
Ingredient:lamotrigine
Patents:0
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078134
Suppliers and Packaging for NDA: 078134
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE lamotrigine TABLET;ORAL 078134 ANDA West-ward Pharmaceutical Corp 0143-9964 E 0143-9964-10
LAMOTRIGINE lamotrigine TABLET;ORAL 078134 ANDA West-ward Pharmaceutical Corp 0143-9964 E 0143-9964-60

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Apr 19, 2011TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Apr 19, 2011TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength150MG
Approval Date:Apr 19, 2011TE:RLD:No

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