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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
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Cipla
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US Department of Justice
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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076017

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NDA 076017 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 076017
Tradename:GABAPENTIN
Applicant:Ivax Sub Teva Pharms
Ingredient:gabapentin
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 076017
Suppliers and Packaging for NDA: 076017
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin TABLET;ORAL 076017 ANDA Teva Pharmaceuticals USA, Inc. 0093-4443 N 0093-4443-01
GABAPENTIN gabapentin TABLET;ORAL 076017 ANDA Teva Pharmaceuticals USA, Inc. 0093-4443 N 0093-4443-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Apr 28, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Apr 28, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Apr 28, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Farmers Insurance
Colorcon
Medtronic
Federal Trade Commission
QuintilesIMS
Fuji
Daiichi Sankyo
Julphar

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