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Serving leading biopharmaceutical companies globally:

Citi
Harvard Business School
Cerilliant
Daiichi Sankyo
Julphar
Chubb
Teva
Express Scripts
Queensland Health
Moodys

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201168

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NDA 201168 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-five 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-six suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

Summary for 201168

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

Pharmacology for NDA: 201168

Suppliers and Packaging for NDA: 201168

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE lamotrigine TABLET, CHEWABLE;ORAL 201168 ANDA Alembic Pharmaceuticals Limited 46708-095 46708-095-31 100 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-31)
LAMOTRIGINE lamotrigine TABLET, CHEWABLE;ORAL 201168 ANDA Alembic Pharmaceuticals Limited 46708-095 46708-095-91 1000 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-91)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength5MG
Approval Date:Jun 12, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength25MG
Approval Date:Jun 12, 2014TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Accenture
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Baxter
Farmers Insurance
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Covington
AstraZeneca
Teva
Express Scripts
Merck

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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