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Last Updated: September 25, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091517

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NDA 091517 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 091517
Tradename:REPAGLINIDE
Applicant:Boscogen
Ingredient:repaglinide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091517
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 091517
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REPAGLINIDE repaglinide TABLET;ORAL 091517 ANDA Breckenridge Pharmaceutical, Inc. 51991-853 51991-853-01 100 TABLET in 1 BOTTLE (51991-853-01)
REPAGLINIDE repaglinide TABLET;ORAL 091517 ANDA Breckenridge Pharmaceutical, Inc. 51991-854 51991-854-01 100 TABLET in 1 BOTTLE (51991-854-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Apr 24, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Apr 24, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Apr 24, 2015TE:ABRLD:No

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