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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 091220


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NDA 091220 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, Norvium Bioscience, 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 091220
Tradename:GLIMEPIRIDE
Applicant:Micro Labs
Ingredient:glimepiride
Patents:0
Pharmacology for NDA: 091220
Suppliers and Packaging for NDA: 091220
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIMEPIRIDE glimepiride TABLET;ORAL 091220 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8332 0615-8332-39 30 TABLET in 1 BLISTER PACK (0615-8332-39)
GLIMEPIRIDE glimepiride TABLET;ORAL 091220 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8333 0615-8333-39 30 TABLET in 1 BLISTER PACK (0615-8333-39)

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;ORALStrength3MG
Approval Date:Jun 29, 2012TE:RLD:No

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