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Last Updated: February 20, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204989


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NDA 204989 describes GABAPENTIN, which is a drug marketed by Aci Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cspc Ouyi, Epic Pharma Llc, Granules India Ltd, 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, Acella Pharms Llc, Amneal Pharms, Hi Tech Pharma, 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 NDAs. It is available from seventy-one 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-four suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 204989
Tradename:GABAPENTIN
Applicant:Sciegen Pharms Inc
Ingredient:gabapentin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204989
Suppliers and Packaging for NDA: 204989
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin CAPSULE;ORAL 204989 ANDA Marlex Pharmaceuticals Inc 10135-644 10135-644-01 100 CAPSULE in 1 BOTTLE, PLASTIC (10135-644-01)
GABAPENTIN gabapentin CAPSULE;ORAL 204989 ANDA Marlex Pharmaceuticals Inc 10135-644 10135-644-05 500 CAPSULE in 1 BOTTLE, PLASTIC (10135-644-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 18, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Feb 18, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength400MG
Approval Date:Feb 18, 2016TE:ABRLD:No

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