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Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077624

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NDA 077624 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, Mylan, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Teva, Viva Hlthcare, and Watson Labs, and is included in seventeen NDAs. It is available from forty-three suppliers. Additional details are available on the GLIMEPIRIDE profile page.

The generic ingredient in GLIMEPIRIDE is glimepiride. There are fifteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the glimepiride profile page.
Summary for 077624
Tradename:GLIMEPIRIDE
Applicant:Mylan
Ingredient:glimepiride
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 077624
Ingredient-typeSulfonylurea Compounds
Suppliers and Packaging for NDA: 077624
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIMEPIRIDE glimepiride TABLET;ORAL 077624 ANDA Mylan Pharmaceuticals Inc. 0378-4011 N 0378-4011-01
GLIMEPIRIDE glimepiride TABLET;ORAL 077624 ANDA Mylan Pharmaceuticals Inc. 0378-4012 N 0378-4012-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Nov 28, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Nov 28, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Nov 28, 2005TE:ABRLD:No

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