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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 087511

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NDA 087511 describes SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE, which is a drug marketed by Ivax Pharms, Lederle, Parke Davis, Purepac Pharm, Upsher Smith, Usl Pharma, Vangard, and Watson Labs, and is included in nine NDAs. Additional details are available on the SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE 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 087511

Tradename:	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
Applicant:	Lederle
Ingredient:	hydrochlorothiazide; spironolactone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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