You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213812

✉ Email this page to a colleague

« Back to Dashboard

NDA 213812 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 213812

Tradename:	EPLERENONE
Applicant:	Annora Pharma
Ingredient:	eplerenone
Patents:	0

Pharmacology for NDA: 213812

Mechanism of Action	Aldosterone Antagonists

Suppliers and Packaging for NDA: 213812

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPLERENONE	eplerenone	TABLET;ORAL	213812	ANDA	Camber Pharmaceuticals, Inc.	31722-049	31722-049-30	30 TABLET, FILM COATED in 1 BOTTLE (31722-049-30)
EPLERENONE	eplerenone	TABLET;ORAL	213812	ANDA	Camber Pharmaceuticals, Inc.	31722-049	31722-049-90	90 TABLET, FILM COATED in 1 BOTTLE (31722-049-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jun 2, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jun 2, 2023	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.