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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
McKesson
Teva
Farmers Insurance
Citi
Express Scripts
Johnson and Johnson
Julphar
Deloitte

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075435

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NDA 075435 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 seven 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 ten suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 075435
Tradename:GABAPENTIN
Applicant:Teva Pharms
Ingredient:gabapentin
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 075435
Suppliers and Packaging for NDA: 075435
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin CAPSULE;ORAL 075435 ANDA MedVantx Inc. 66116-444 E 66116-444-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Oct 8, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Oct 8, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength400MG
Approval Date:Oct 8, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
US Army
Dow
Merck
Medtronic
US Department of Justice
Argus Health
Fuji
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