Details for New Drug Application (NDA): 089534

NDA 089534 describes SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ascot, Chartwell Rx, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, and Watson Labs, and is included in eight NDAs. It is available from four suppliers. Additional details are available on the SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE 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 089534

Tradename:	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Applicant:	Sun Pharm Industries
Ingredient:	hydrochlorothiazide; spironolactone
Patents:	0

Pharmacology for NDA: 089534

Mechanism of Action	Aldosterone Antagonists
Physiological Effect	Increased Diuresis

Suppliers and Packaging for NDA: 089534

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	089534	ANDA	Sun Pharmaceutical Industries, Inc.	53489-144	53489-144-01	100 TABLET in 1 BOTTLE, PLASTIC (53489-144-01)
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	089534	ANDA	Sun Pharmaceutical Industries, Inc.	53489-144	53489-144-05	500 TABLET in 1 BOTTLE, PLASTIC (53489-144-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;25MG
Approval Date:	Jul 2, 1987	TE:	AB	RLD:	No

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