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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 040353

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NDA 040353 describes SPIRONOLACTONE, which is a drug marketed by Amneal, Hetero Labs Ltd Iii, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Annora Pharma, Ascot, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Oxford Pharms, Pharmobedient, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, Zydus Pharms, Parke Davis, and Usl Pharma, and is included in forty-four NDAs. It is available from thirty-five suppliers. Additional details are available on the SPIRONOLACTONE profile page.

The generic ingredient in SPIRONOLACTONE is hydrochlorothiazide; spironolactone. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.

Summary for 040353

Tradename:	SPIRONOLACTONE
Applicant:	Actavis Elizabeth
Ingredient:	spironolactone
Patents:	0

Medical Subject Heading (MeSH) Categories for 040353

Diuretics
Mineralocorticoid Receptor Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jul 29, 1999	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jul 29, 1999	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 15, 2006	TE:		RLD:	No

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