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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 078482

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NDA 078482 describes EPLERENONE, which is a drug marketed by Aarxion Anda Hlding, Accord Hlthcare, Adaptis, Annora Pharma, Breckenridge, Chartwell Rx, Rising, Sandoz, and Westminster Pharms, and is included in nine NDAs. It is available from ten 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. Twelve suppliers are listed for this compound. Additional details are available on the eplerenone profile page.

Summary for 078482

Tradename:	EPLERENONE
Applicant:	Chartwell Rx
Ingredient:	eplerenone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jul 30, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jul 30, 2008	TE:	AB	RLD:	No

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