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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203512
Company: ACCORD HLTHCARE

Products on ANDA 203512

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET;ORAL	Prescription	AB	No	No
SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET;ORAL	Prescription	AB	No	No
SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203512

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/2016	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
04/25/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/26/2021	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/05/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203512

SPIRONOLACTONE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALDACTONE	SPIRONOLACTONE	25MG	TABLET;ORAL	Prescription	Yes	AB	012151	PFIZER
SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET;ORAL	Prescription	No	AB	203512	ACCORD HLTHCARE
SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET;ORAL	Prescription	No	AB	091426	AMNEAL PHARMS
SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET;ORAL	Prescription	No	AB	202187	AUROBINDO PHARMA
SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET;ORAL	Prescription	No	AB	203253	JUBILANT GENERICS
SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET;ORAL	Prescription	No	AB	040424	MYLAN
SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET;ORAL	Prescription	No	AB	040750	OXFORD PHARMS
SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET;ORAL	Prescription	No	AB	089424	SUN PHARM INDUSTRIES
SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET;ORAL	Prescription	No	AB	205936	ZYDUS PHARMS

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALDACTONE	SPIRONOLACTONE	50MG	TABLET;ORAL	Prescription	Yes	AB	012151	PFIZER
SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET;ORAL	Prescription	No	AB	203512	ACCORD HLTHCARE
SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET;ORAL	Prescription	No	AB	091426	AMNEAL PHARMS
SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET;ORAL	Prescription	No	AB	202187	AUROBINDO PHARMA
SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET;ORAL	Prescription	No	AB	203253	JUBILANT GENERICS
SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET;ORAL	Prescription	No	AB	040424	MYLAN
SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET;ORAL	Prescription	No	AB	040750	OXFORD PHARMS
SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET;ORAL	Prescription	No	AB	089424	SUN PHARM INDUSTRIES
SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET;ORAL	Prescription	No	AB	205936	ZYDUS PHARMS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALDACTONE	SPIRONOLACTONE	100MG	TABLET;ORAL	Prescription	Yes	AB	012151	PFIZER
SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET;ORAL	Prescription	No	AB	203512	ACCORD HLTHCARE
SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET;ORAL	Prescription	No	AB	091426	AMNEAL PHARMS
SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET;ORAL	Prescription	No	AB	202187	AUROBINDO PHARMA
SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET;ORAL	Prescription	No	AB	203253	JUBILANT GENERICS
SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET;ORAL	Prescription	No	AB	040424	MYLAN
SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET;ORAL	Prescription	No	AB	040750	OXFORD PHARMS
SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET;ORAL	Prescription	No	AB	089424	SUN PHARM INDUSTRIES
SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET;ORAL	Prescription	No	AB	205936	ZYDUS PHARMS

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