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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Merck
Harvard Business School
Express Scripts
Citi
UBS
Fish and Richardson
Healthtrust
Teva
QuintilesIMS

Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090007

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NDA 090007 describes GABAPENTIN, which is a drug marketed by Sciegen Pharms Inc, Alkem Labs Ltd, Acella Pharms Llc, Invagen Pharms, Ranbaxy, Sun Pharm Inds Ltd, Marksans Pharma, Teva Pharms Usa, Ivax Sub Teva Pharms, Sandoz, Amneal Pharms, Zydus Pharms Usa Inc, Teva, Amneal Pharms Ny, Teva Pharms, Mylan Pharms Inc, Sun Pharm Inds, Aci Healthcare Ltd, Actavis Elizabeth, Hikma, Aurobindo Pharma Ltd, Alkem, Mylan, Apotex Inc, Taro Pharm, Glenmark Pharms Ltd, Taro, Hi Tech Pharma, Hikma Pharms, Watson Labs, Tris Pharma Inc, and Epic Pharma Llc, and is included in forty-four NDAs. It is available from one hundred and three 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 six suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

Summary for NDA: 090007

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

Pharmacology for NDA: 090007

Suppliers and Packaging for NDA: 090007

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN
gabapentin
CAPSULE;ORAL 090007 ANDA MARKSANS PHARMA LIMITED 25000-103 25000-103-01 4000 CAPSULE in 1 BAG (25000-103-01)
GABAPENTIN
gabapentin
CAPSULE;ORAL 090007 ANDA MARKSANS PHARMA LIMITED 25000-103 25000-103-03 30 CAPSULE in 1 BOTTLE (25000-103-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 21, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Jul 21, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength400MG
Approval Date:Jul 21, 2011TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Queensland Health
Teva
Merck
Chinese Patent Office
McKesson
Johnson and Johnson
Medtronic
Fish and Richardson
Argus Health
US Army

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