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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 089364

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NDA 089364 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 089364

Tradename:	SPIRONOLACTONE
Applicant:	Superpharm
Ingredient:	spironolactone
Patents:	0

Medical Subject Heading (MeSH) Categories for 089364

Diuretics
Mineralocorticoid Receptor Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Nov 7, 1986	TE:		RLD:	No

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