BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Cerilliant
Citi
Accenture
Colorcon
Teva
Merck
Chubb
Cantor Fitzgerald
McKesson
Mallinckrodt

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075795

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NDA 075795 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-four 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. Fourteen suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.
Summary for 075795
Tradename:GLIPIZIDE
Applicant:Apotex
Ingredient:glipizide
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 075795
Ingredient-typeSulfonylurea Compounds
Medical Subject Heading (MeSH) Categories for 075795
Suppliers and Packaging for NDA: 075795
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIPIZIDE glipizide TABLET;ORAL 075795 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7968 0615-7968-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7968-30) > 5 TABLET in 1 BLISTER PACK
GLIPIZIDE glipizide TABLET;ORAL 075795 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7968 0615-7968-39 30 TABLET in 1 BLISTER PACK (0615-7968-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 13, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 13, 2001TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Cantor Fitzgerald
Chinese Patent Office
Express Scripts
Novartis
Healthtrust
Dow
Mallinckrodt
Julphar

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