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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Federal Trade Commission
Cipla
Fish and Richardson
QuintilesIMS
Medtronic
Moodys
Cerilliant
Daiichi Sankyo
McKesson

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077661

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NDA 077661 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 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 077661
Tradename:GABAPENTIN
Applicant:Apotex Inc
Ingredient:gabapentin
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 077661
Suppliers and Packaging for NDA: 077661
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin TABLET;ORAL 077661 ANDA Golden State Medical Supply, Inc. 60429-782 60429-782-01 100 TABLET, FILM COATED in 1 BOTTLE (60429-782-01)
GABAPENTIN gabapentin TABLET;ORAL 077661 ANDA Golden State Medical Supply, Inc. 60429-782 60429-782-05 500 TABLET, FILM COATED in 1 BOTTLE (60429-782-05)

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Sep 13, 2006TE:ABRLD:No

Profile for product number 005

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Sep 13, 2006TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Fuji
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Healthtrust
AstraZeneca
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Johnson and Johnson
Express Scripts
Baxter
Colorcon

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