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

Serving hundreds of leading biopharmaceutical companies globally:

Teva
Fuji
Healthtrust
Harvard Business School
Queensland Health
Moodys
Covington
Cipla
Deloitte

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076159

« Back to Dashboard

NDA 076159 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. Thirteen suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.
Summary for 076159
Tradename:GLIPIZIDE
Applicant:Par Pharm
Ingredient:glipizide
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 076159
Ingredient-typeSulfonylurea Compounds
Medical Subject Heading (MeSH) Categories for 076159
Suppliers and Packaging for NDA: 076159
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIPIZIDE glipizide TABLET, EXTENDED RELEASE;ORAL 076159 ANDA Par Pharmaceutical, Inc. 10370-745 N 10370-745-01
GLIPIZIDE glipizide TABLET, EXTENDED RELEASE;ORAL 076159 ANDA Par Pharmaceutical, Inc. 10370-745 N 10370-745-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Sep 20, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Sep 20, 2013TE:ABRLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
AstraZeneca
Merck
Mallinckrodt
Chubb
Farmers Insurance
Healthtrust
Chinese Patent Office

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.