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Serving leading biopharmaceutical companies globally:

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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090335

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NDA 090335 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 090335
Tradename:GABAPENTIN
Applicant:Mylan Pharms Inc
Ingredient:gabapentin
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 090335
Suppliers and Packaging for NDA: 090335
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin TABLET;ORAL 090335 ANDA Mylan Pharmaceuticals Inc. 0378-5424 0378-5424-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-5424-01)
GABAPENTIN gabapentin TABLET;ORAL 090335 ANDA Mylan Pharmaceuticals Inc. 0378-5424 0378-5424-05 500 TABLET in 1 BOTTLE, PLASTIC (0378-5424-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jun 1, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Jun 1, 2010TE:ABRLD:No

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