An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078482
Company: CHARTWELL RX

Products on ANDA 078482

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	AB	No	No
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078482

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078482s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/11/2013	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078482

EPLERENONE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	206922	ACCORD HLTHCARE
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	212765	ADAPTIS
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	213812	ANNORA PHARMA
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	208283	BRECKENRIDGE
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	078482	CHARTWELL RX
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	214663	RISING
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	078510	SANDOZ
EPLERENONE	EPLERENONE	25MG	TABLET;ORAL	Prescription	No	AB	207842	WESTMINSTER PHARMS
INSPRA	EPLERENONE	25MG	TABLET;ORAL	Prescription	Yes	AB	021437	UPJOHN

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	206922	ACCORD HLTHCARE
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	212765	ADAPTIS
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	213812	ANNORA PHARMA
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	208283	BRECKENRIDGE
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	078482	CHARTWELL RX
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	214663	RISING
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	078510	SANDOZ
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	207842	WESTMINSTER PHARMS
INSPRA	EPLERENONE	50MG	TABLET;ORAL	Prescription	Yes	AB	021437	UPJOHN

Top