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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078510
Company: SANDOZ

Products on ANDA 078510

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 078510

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/01/2008	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/02/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/14/2014	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
09/16/2015	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
02/20/2013	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/20/2013	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
05/13/2011	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 078510

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	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	212765	SLATE RUN PHARMA
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	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	212765	SLATE RUN PHARMA
EPLERENONE	EPLERENONE	50MG	TABLET;ORAL	Prescription	No	AB	207842	WESTMINSTER PHARMS
INSPRA	EPLERENONE	50MG	TABLET;ORAL	Prescription	Yes	AB	021437	UPJOHN

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