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:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG;1MG
Approval Date:	Jun 23, 2008	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG;2MG
Approval Date:	Jun 23, 2008	TE:		RLD:	Yes

Expired US Patents for NDA 022386

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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	⤷ Subscribe	⤷ Subscribe
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-002	Jun 23, 2008	⤷ Subscribe	⤷ Subscribe
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-002	Jun 23, 2008	⤷ Subscribe	⤷ Subscribe
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-001	Jun 23, 2008	⤷ Subscribe	⤷ Subscribe
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