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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Deloitte
AstraZeneca
Queensland Health
Argus Health
Chinese Patent Office
QuintilesIMS
McKesson
McKinsey

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090858

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NDA 090858 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 090858
Tradename:GABAPENTIN
Applicant:Alkem
Ingredient:gabapentin
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 090858
Suppliers and Packaging for NDA: 090858
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin CAPSULE;ORAL 090858 ANDA Major Pharmaceuticals 0904-6666 N 0904-6666-61
GABAPENTIN gabapentin CAPSULE;ORAL 090858 ANDA Major Pharmaceuticals 0904-6667 N 0904-6667-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 17, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Dec 17, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength400MG
Approval Date:Dec 17, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
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Cantor Fitzgerald
Fish and Richardson
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US Army
Healthtrust
Mallinckrodt
Fuji

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