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Last Updated: December 26, 2024

Details for New Drug Application (NDA): 086898

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NDA 086898 describes SPIRONOLACTONE, which is a drug marketed by Amneal, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma, Chartwell Rx, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Norvium Bioscience, Oxford Pharms, 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-one NDAs. It is available from forty 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. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.

Summary for 086898

Tradename:	SPIRONOLACTONE
Applicant:	Watson Labs
Ingredient:	spironolactone
Patents:	0

Medical Subject Heading (MeSH) Categories for 086898

Diuretics
Mineralocorticoid Receptor Antagonists

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 2, 1982	TE:		RLD:	No

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