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Last Updated: September 27, 2020

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Details for New Drug Application (NDA): 203820

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NDA 203820 describes REPAGLINIDE, which is a drug marketed by Actavis Totowa, Aurobindo Pharma Ltd, Boscogen, Casi Pharms Inc, Mylan, Paddock Llc, Sun Pharm Inds Inc, and Lupin Ltd, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the REPAGLINIDE profile page.

The generic ingredient in REPAGLINIDE is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.
Summary for 203820
Tradename:REPAGLINIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:repaglinide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203820
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 203820
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REPAGLINIDE repaglinide TABLET;ORAL 203820 ANDA Rising Health, LLC 57237-157 57237-157-01 100 TABLET in 1 BOTTLE (57237-157-01)
REPAGLINIDE repaglinide TABLET;ORAL 203820 ANDA Rising Health, LLC 57237-157 57237-157-05 500 TABLET in 1 BOTTLE (57237-157-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jan 22, 2014TE: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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