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Generated: December 12, 2018

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Details for New Drug Application (NDA): 203244

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NDA 203244 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, Strides Pharma, 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-nine 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 203244
Tradename:GABAPENTIN
Applicant:Aci Healthcare Ltd
Ingredient:gabapentin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203244
Suppliers and Packaging for NDA: 203244
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin TABLET;ORAL 203244 ANDA Solco Healthcare U.S., LLC 43547-332 43547-332-10 100 TABLET, FILM COATED in 1 BOTTLE (43547-332-10)
GABAPENTIN gabapentin TABLET;ORAL 203244 ANDA Solco Healthcare U.S., LLC 43547-332 43547-332-50 500 TABLET, FILM COATED in 1 BOTTLE (43547-332-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Jul 12, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jul 12, 2013TE:ABRLD:No

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