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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Covington
Teva
Johnson and Johnson
Citi
QuintilesIMS
McKinsey
Harvard Business School
Merck

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075694

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NDA 075694 describes GABAPENTIN, which is a drug marketed by 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, Aci Healthcare Ltd, 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-six NDAs. It is available from one hundred and five 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 eight suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 075694
Tradename:GABAPENTIN
Applicant:Actavis Elizabeth
Ingredient:gabapentin
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 075694
Suppliers and Packaging for NDA: 075694
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin TABLET;ORAL 075694 ANDA Actavis Pharma, Inc. 0228-2636 N 0228-2636-11
GABAPENTIN gabapentin TABLET;ORAL 075694 ANDA Actavis Pharma, Inc. 0228-2636 N 0228-2636-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Oct 21, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Oct 21, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cerilliant
QuintilesIMS
Harvard Business School
Colorcon
Chubb
US Army
AstraZeneca
Johnson and Johnson

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