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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 202759


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NDA 202759 describes GLIMEPIRIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anda Repository, Aurobindo Pharma Ltd, Carlsbad, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Micro Labs, Mylan, Prinston Inc, Quagen, Ranbaxy, Ranbaxy Labs Ltd, Regcon Holdings, and Watson Labs, and is included in seventeen NDAs. It is available from thirty-one suppliers. Additional details are available on the GLIMEPIRIDE profile page.

The generic ingredient in GLIMEPIRIDE is glimepiride. There are sixteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the glimepiride profile page.
Summary for 202759
Tradename:GLIMEPIRIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:glimepiride
Patents:0
Pharmacology for NDA: 202759
Suppliers and Packaging for NDA: 202759
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIMEPIRIDE glimepiride TABLET;ORAL 202759 ANDA Rising Pharma Holdings, Inc. 16571-773 16571-773-01 100 TABLET in 1 BOTTLE (16571-773-01)
GLIMEPIRIDE glimepiride TABLET;ORAL 202759 ANDA Rising Pharma Holdings, Inc. 16571-773 16571-773-50 500 TABLET in 1 BOTTLE (16571-773-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 29, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jun 29, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Jun 29, 2012TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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