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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 206928


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NDA 206928 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 206928
Tradename:GLIPIZIDE
Applicant:Aurobindo Pharma
Ingredient:glipizide
Patents:0
Pharmacology for NDA: 206928
Medical Subject Heading (MeSH) Categories for 206928
Suppliers and Packaging for NDA: 206928
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIPIZIDE glipizide TABLET, EXTENDED RELEASE;ORAL 206928 ANDA A-S Medication Solutions 50090-4297 50090-4297-0 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4297-0)
GLIPIZIDE glipizide TABLET, EXTENDED RELEASE;ORAL 206928 ANDA A-S Medication Solutions 50090-4297 50090-4297-2 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4297-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:May 12, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:May 12, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 12, 2017TE:ABRLD:No

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