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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078555

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NDA 078555 describes REPAGLINIDE, which is a drug marketed by Actavis Totowa, Aurobindo Pharma Ltd, Boscogen, Mylan Pharms Inc, Paddock Llc, Sandoz Inc, Sun Pharm Inds Inc, and Lupin Ltd, and is included in eight NDAs. It is available from twelve suppliers. Additional details are available on the REPAGLINIDE profile page.

The generic ingredient in REPAGLINIDE is metformin hydrochloride; repaglinide. There are forty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.
Summary for 078555
Tradename:REPAGLINIDE
Applicant:Sandoz Inc
Ingredient:repaglinide
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 078555
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 078555
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REPAGLINIDE repaglinide TABLET;ORAL 078555 ANDA Sandoz Inc 0781-5148 0781-5148-05 500 TABLET in 1 BOTTLE (0781-5148-05)
REPAGLINIDE repaglinide TABLET;ORAL 078555 ANDA Sandoz Inc 0781-5148 0781-5148-13 100 BLISTER PACK in 1 DOSE PACK (0781-5148-13) > 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Nov 22, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jan 22, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jan 22, 2014TE:ABRLD:No

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