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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077525

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NDA 077525 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 077525

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 077525

Suppliers and Packaging for NDA: 077525

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin TABLET;ORAL 077525 ANDA STAT RX USA LLC 16590-104 16590-104-72 120 TABLET, FILM COATED in 1 BOTTLE (16590-104-72)
GABAPENTIN gabapentin TABLET;ORAL 077525 ANDA STAT RX USA LLC 16590-104 16590-104-60 60 TABLET, FILM COATED in 1 BOTTLE (16590-104-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Aug 24, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Aug 24, 2006TE:ABRLD:No


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