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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 075795


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NDA 075795 describes GLIPIZIDE, which is a drug marketed by Aurobindo Pharma, Endo Operations, Norvium Bioscience, Unique, Watson Labs, Zydus Pharms, Accord Hlthcare, Ani Pharms, Apotex, Aurobindo Pharma Usa, Barr Labs Inc, Chartwell Rx, Oxford Pharms, Rubicon, Sandoz, Sun Pharm Inds Inc, Watson Labs Teva, Dash Pharms, Epic Pharma Llc, Heritage, Teva Pharms, and Zydus Pharms Usa Inc, and is included in twenty-six NDAs. It is available from forty 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. Nine 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
Pharmacology for NDA: 075795
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 Major Pharmaceuticals 0904-6637 0904-6637-61 100 BLISTER PACK in 1 CARTON (0904-6637-61) / 1 TABLET in 1 BLISTER PACK
GLIPIZIDE glipizide TABLET;ORAL 075795 ANDA QPharma Inc 42708-109 42708-109-30 30 TABLET in 1 BOTTLE (42708-109-30)

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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