.

Make Better Decisions

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

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

Serving leading biopharmaceutical companies globally:

Queensland Health
Federal Trade Commission
Chinese Patent Office
Cantor Fitzgerald
Argus Health
Novartis
Medtronic
QuintilesIMS
Baxter
US Army

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076467

« Back to Dashboard

NDA 076467 describes GLIPIZIDE, which is a drug marketed by Aurobindo Pharma Ltd, Mylan Pharms Inc, Par Pharm, Unique Pharm Labs, Watson Labs, Accord Hlthcare, Ani Pharms Inc, Apotex, Barr Labs Inc, Mylan, Sandoz, Sun Pharm Inds Inc, Vintage Pharms Llc, Watson Labs Teva, Epic Pharma Llc, Heritage Pharms Inc, Teva Pharms, and Zydus Pharms Usa Inc, and is included in twenty-four NDAs. It is available from fifty-two suppliers. Additional details are available on the GLIPIZIDE profile page.

The generic ingredient in GLIPIZIDE is glipizide; metformin hydrochloride. There are eighteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.

Summary for 076467

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 076467

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 076467

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIPIZIDE glipizide TABLET, EXTENDED RELEASE;ORAL 076467 ANDA Actavis Elizabeth LLC 0228-2898 0228-2898-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2898-03)
GLIPIZIDE glipizide TABLET, EXTENDED RELEASE;ORAL 076467 ANDA Actavis Elizabeth LLC 0228-2899 0228-2899-96 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2899-96)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Sep 8, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Nov 7, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:Mar 27, 2006TE: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:

Merck
US Army
Chubb
Baxter
Moodys
Julphar
Mallinckrodt
US Department of Justice
Federal Trade Commission
Cantor Fitzgerald

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