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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 078510

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NDA 078510 describes EPLERENONE, which is a drug marketed by Accord Hlthcare, Annora Pharma, Breckenridge, Chartwell Rx, Prasco, Rising, Sandoz, Slate Run Pharma, and Westminster Pharms, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the EPLERENONE profile page.

The generic ingredient in EPLERENONE 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 078510

Tradename:	EPLERENONE
Applicant:	Sandoz
Ingredient:	eplerenone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Aug 1, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Aug 1, 2008	TE:	AB	RLD:	No

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