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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078952


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NDA 078952 describes GLIMEPIRIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Carlsbad, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Indoco Remedies, Micro Labs, Mylan, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Teva, 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 078952
Tradename:GLIMEPIRIDE
Applicant:Hikma Pharms
Ingredient:glimepiride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG
Approval Date:Aug 1, 2013TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2MG
Approval Date:Aug 1, 2013TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength4MG
Approval Date:Aug 1, 2013TE:RLD:No

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