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Last Updated: November 5, 2024

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. 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

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

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