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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020741

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NDA 020741 describes PRANDIN, which is a drug marketed by Gemini Labs Llc and is included in one NDA. It is available from four suppliers. Additional details are available on the PRANDIN profile page.

The generic ingredient in PRANDIN is repaglinide. There are sixteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the repaglinide profile page.

Summary for 020741

Tradename:	PRANDIN
Applicant:	Gemini Labs Llc
Ingredient:	repaglinide
Patents:	0
Therapeutic Class:	Blood Glucose Regulators
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020741

Mechanism of Action	Potassium Channel Antagonists

Suppliers and Packaging for NDA: 020741

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRANDIN	repaglinide	TABLET;ORAL	020741	NDA	Novo Nordisk	0169-0081	N	0169-0081-80
PRANDIN	repaglinide	TABLET;ORAL	020741	NDA	Novo Nordisk	0169-0081	N	0169-0081-81

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Dec 22, 1997	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Dec 22, 1997	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Dec 22, 1997	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020741

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997	➤ Sign Up	➤ Sign Up
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-001	Dec 22, 1997	➤ Sign Up	➤ Sign Up
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-001	Dec 22, 1997	➤ Sign Up	➤ Sign Up
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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