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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076403

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NDA 076403 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, Alkem Labs Ltd, Apotex Inc, Glenmark Pharms Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Lupin Ltd, Mylan Pharms Inc, Ranbaxy, Rubicon, Teva, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in forty-nine NDAs. It is available from seventy-nine 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. Eighty-two suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 076403
Tradename:GABAPENTIN
Applicant:Acella Pharms Llc
Ingredient:gabapentin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076403
Suppliers and Packaging for NDA: 076403
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin SOLUTION;ORAL 076403 ANDA ATLANTIC BIOLOGICALS CORP. 17856-0600 17856-0600-1 72 CUP, UNIT-DOSE in 1 BOX (17856-0600-1) > 5 mL in 1 CUP, UNIT-DOSE
GABAPENTIN gabapentin SOLUTION;ORAL 076403 ANDA ATLANTIC BIOLOGICALS CORP. 17856-0600 17856-0600-2 72 CUP, UNIT-DOSE in 1 BOX (17856-0600-2) > 6 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength250MG/5ML
Approval Date:May 1, 2012TE:AARLD:No

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