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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040424
Company: MYLAN

Products on ANDA 040424

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 040424

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2001	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-424_Spironolactone_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40424ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/040424_spironolactone_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2023	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
02/26/2021	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
11/14/2019	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
04/26/2015	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
09/23/2014	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/23/2014	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
02/25/2009	SUPPL-11	Labeling		Label is not available on this site.
06/09/2003	SUPPL-4	Labeling		Label is not available on this site.
05/21/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 040424

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-424_Spironolactone_Prntlbl.pdf

Therapeutic Equivalents for ANDA 040424

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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