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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022386

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NDA 022386 describes PRANDIMET, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. Additional details are available on the PRANDIMET profile page.

The generic ingredient in PRANDIMET is metformin hydrochloride; repaglinide. There are forty-nine 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 022386
Tradename:PRANDIMET
Applicant:Novo Nordisk Inc
Ingredient:metformin hydrochloride; repaglinide
Patents:0
Paragraph IV (Patent) Challenges for 022386
Tradename Dosage Ingredient NDA Submissiondate
PRANDIMET TABLET;ORAL metformin hydrochloride; repaglinide 022386 2009-04-09

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;1MG
Approval Date:Jun 23, 2008TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;2MG
Approval Date:Jun 23, 2008TE:RLD:Yes

Expired US Patents for NDA 022386

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-001 Jun 23, 2008   Start Trial   Start Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-002 Jun 23, 2008   Start Trial   Start Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-002 Jun 23, 2008   Start Trial   Start Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-001 Jun 23, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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