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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212765

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NDA 212765 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 212765

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

Pharmacology for NDA: 212765

Mechanism of Action	Aldosterone Antagonists

Suppliers and Packaging for NDA: 212765

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPLERENONE	eplerenone	TABLET;ORAL	212765	ANDA	Slate Run Pharmaceuticals, LLC	70436-098	70436-098-01	100 TABLET, FILM COATED in 1 BOTTLE (70436-098-01)
EPLERENONE	eplerenone	TABLET;ORAL	212765	ANDA	Slate Run Pharmaceuticals, LLC	70436-098	70436-098-04	30 TABLET, FILM COATED in 1 BOTTLE (70436-098-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Aug 10, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Aug 10, 2020	TE:	AB	RLD:	No

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