Details for New Drug Application (NDA): 021437

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NDA 021437 describes INSPRA, which is a drug marketed by Upjohn and is included in one NDA. It is available from three suppliers. Additional details are available on the INSPRA profile page.

The generic ingredient in INSPRA is eplerenone. There are five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the eplerenone profile page.

Summary for 021437

Tradename:	INSPRA
Applicant:	Upjohn
Ingredient:	eplerenone
Patents:	0

Pharmacology for NDA: 021437

Mechanism of Action	Aldosterone Antagonists

Suppliers and Packaging for NDA: 021437

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INSPRA	eplerenone	TABLET;ORAL	021437	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1710	0025-1710-01	30 TABLET, FILM COATED in 1 BOTTLE (0025-1710-01)
INSPRA	eplerenone	TABLET;ORAL	021437	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1720	0025-1720-03	30 TABLET, FILM COATED in 1 BOTTLE (0025-1720-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Sep 27, 2002	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 27, 2002	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 27, 2002	TE:		RLD:	No

Expired US Patents for NDA 021437

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-002	Sep 27, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-002	Sep 27, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-002	Sep 27, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-001	Sep 27, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-003	Sep 27, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-003	Sep 27, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-001	Sep 27, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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