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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Fuji
Daiichi Sankyo
Express Scripts
Deloitte
AstraZeneca
Covington
Baxter
Mallinckrodt

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078782

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NDA 078782 describes GABAPENTIN, which is a drug marketed by Aci Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Epic Pharma Llc, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro Pharm, Teva Pharms, Watson Labs, Acella Pharms Llc, Amneal Pharms, Hi Tech Pharma, Taro, Tris Pharma Inc, Alkem Labs Ltd, Glenmark Pharms Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Mylan Pharms Inc, Ranbaxy, Teva, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in forty-seven NDAs. It is available from one hundred and six suppliers. Additional details are available on the GABAPENTIN profile page.

The generic ingredient in GABAPENTIN is gabapentin. There are twenty-eight drug master file entries for this compound. One hundred and nine suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 078782
Tradename:GABAPENTIN
Applicant:Hikma Pharms
Ingredient:gabapentin
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength600MG
Approval Date:Jul 21, 2011TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength800MG
Approval Date:Jul 21, 2011TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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Dow
Baxter
Cerilliant
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Federal Trade Commission
Healthtrust
Moodys

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