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Last Updated: October 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078926


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NDA 078926 describes GABAPENTIN, which is a drug marketed by Aci Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Ascent Pharms Inc, Aurobindo Pharma Ltd, Cspc Ouyi, Granules, Graviti Pharms, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Zhejiang Yongtai, Acella Pharms Llc, Akorn, Amneal Pharms, Tris Pharma Inc, Vistapharm, Alkem Labs Ltd, Apotex Inc, Glenmark Pharms Ltd, Hikma Pharms, Invatech, Ivax Sub Teva Pharms, Lupin Ltd, Mylan Pharms Inc, Ranbaxy, Rubicon, Teva, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in fifty-two NDAs. It is available from seventy-two suppliers. Additional details are available on the GABAPENTIN profile page.

The generic ingredient in GABAPENTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 078926
Tradename:GABAPENTIN
Applicant:Zydus Pharms Usa Inc
Ingredient:gabapentin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078926
Suppliers and Packaging for NDA: 078926
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin TABLET;ORAL 078926 ANDA PD-Rx Pharmaceuticals, Inc. 43063-611 43063-611-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-611-90)
GABAPENTIN gabapentin TABLET;ORAL 078926 ANDA A-S Medication Solutions 50090-3912 50090-3912-0 60 TABLET, FILM COATED in 1 BOTTLE (50090-3912-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Feb 11, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Feb 11, 2011TE:ABRLD:No

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