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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 078181


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NDA 078181 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 078181
Tradename:GLIMEPIRIDE
Applicant:Accord Hlthcare
Ingredient:glimepiride
Patents:0
Pharmacology for NDA: 078181
Suppliers and Packaging for NDA: 078181
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIMEPIRIDE glimepiride TABLET;ORAL 078181 ANDA Accord Healthcare Inc 16729-001 16729-001-01 100 TABLET in 1 BOTTLE (16729-001-01)
GLIMEPIRIDE glimepiride TABLET;ORAL 078181 ANDA Accord Healthcare Inc 16729-001 16729-001-16 500 TABLET in 1 BOTTLE (16729-001-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 23, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Aug 23, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Aug 23, 2007TE:ABRLD:No

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Preferred Citation:

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