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Generated: October 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078787

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NDA 078787 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, Lupin Ltd, Mylan Pharms Inc, Ranbaxy, Teva, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in forty-eight NDAs. It is available from one hundred and eight 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 eleven suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 078787
Tradename:GABAPENTIN
Applicant:Aurobindo Pharma Ltd
Ingredient:gabapentin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078787
Suppliers and Packaging for NDA: 078787
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin CAPSULE;ORAL 078787 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7961 0615-7961-05 15 CAPSULE in 1 BLISTER PACK (0615-7961-05)
GABAPENTIN gabapentin CAPSULE;ORAL 078787 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7961 0615-7961-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7961-30) > 5 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jan 31, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Jan 31, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength400MG
Approval Date:Jan 31, 2008TE:ABRLD:No

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