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Last Updated: May 31, 2020

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Details for New Drug Application (NDA): 202112


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NDA 202112 describes GLIMEPIRIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Carlsbad, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Indoco Remedies, Invagen Pharms, Micro Labs, Mylan, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Teva, and Watson Labs, and is included in seventeen NDAs. It is available from thirty-seven 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-eight suppliers are listed for this compound. Additional details are available on the glimepiride profile page.
Summary for 202112
Tradename:GLIMEPIRIDE
Applicant:Indoco Remedies
Ingredient:glimepiride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202112
Suppliers and Packaging for NDA: 202112
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIMEPIRIDE glimepiride TABLET;ORAL 202112 ANDA A-S Medication Solutions 50090-3189 50090-3189-1 100 TABLET in 1 BOTTLE, PLASTIC (50090-3189-1)
GLIMEPIRIDE glimepiride TABLET;ORAL 202112 ANDA A-S Medication Solutions 50090-3189 50090-3189-3 90 TABLET in 1 BOTTLE, PLASTIC (50090-3189-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Apr 17, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Apr 17, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Apr 17, 2013TE:ABRLD:No

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