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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 077370


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NDA 077370 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-two 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-two suppliers are listed for this compound. Additional details are available on the glimepiride profile page.
Summary for 077370
Tradename:GLIMEPIRIDE
Applicant:Prinston Inc
Ingredient:glimepiride
Patents:0
Pharmacology for NDA: 077370
Suppliers and Packaging for NDA: 077370
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIMEPIRIDE glimepiride TABLET;ORAL 077370 ANDA Solco Healthcare U.S., LLC 43547-394 43547-394-10 100 TABLET in 1 BOTTLE, PLASTIC (43547-394-10)
GLIMEPIRIDE glimepiride TABLET;ORAL 077370 ANDA Solco Healthcare U.S., LLC 43547-394 43547-394-50 500 TABLET in 1 BOTTLE, PLASTIC (43547-394-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 23, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 23, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Dec 23, 2005TE:ABRLD:No

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