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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 203896

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NDA 203896 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 203896

Tradename:	EPLERENONE
Applicant:	Aarxion Anda Hlding
Ingredient:	eplerenone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Feb 2, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Feb 2, 2017	TE:		RLD:	No

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