.

Deeper Knowledge, Faster

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Accenture
Federal Trade Commission
McKinsey
Johnson and Johnson
Express Scripts
Cipla
Colorcon
Cerilliant

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078428

« Back to Dashboard

NDA 078428 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 078428

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

Pharmacology for NDA: 078428

Suppliers and Packaging for NDA: 078428

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin CAPSULE;ORAL 078428 ANDA Liberty Pharmaceuticals, Inc. 0440-7559 0440-7559-94 270 CAPSULE in 1 BOTTLE, PLASTIC (0440-7559-94)
GABAPENTIN gabapentin CAPSULE;ORAL 078428 ANDA Major Pharmaceuticals 0904-6078 0904-6078-61 100 CAPSULE in 1 BOX, UNIT-DOSE (0904-6078-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 25, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Jul 25, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength400MG
Approval Date:Jul 25, 2007TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
QuintilesIMS
Boehringer Ingelheim
Merck
Argus Health
Baxter
Fish and Richardson
Queensland Health
Johnson and Johnson
Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot