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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Medtronic
US Department of Justice
Cipla
Covington
Merck
Express Scripts
Farmers Insurance

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076606

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NDA 076606 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 076606
Tradename:GABAPENTIN
Applicant:Sun Pharm Inds Ltd
Ingredient:gabapentin
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 076606
Suppliers and Packaging for NDA: 076606
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin CAPSULE;ORAL 076606 ANDA Ranbaxy Pharmaceuticals Inc. 63304-627 N 63304-627-01
GABAPENTIN gabapentin CAPSULE;ORAL 076606 ANDA Ranbaxy Pharmaceuticals Inc. 63304-627 N 63304-627-05

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG
Approval Date:Oct 7, 2005TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength300MG
Approval Date:Oct 7, 2005TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength400MG
Approval Date:Oct 7, 2005TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Boehringer Ingelheim
US Army
Express Scripts
Cantor Fitzgerald
Covington
Cipla
US Department of Justice
Mallinckrodt

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