Details for New Drug Application (NDA): 012616

NDA 012616 describes ALDACTAZIDE, which is a drug marketed by Pfizer and is included in one NDA. It is available from three suppliers. Additional details are available on the ALDACTAZIDE profile page.

The generic ingredient in ALDACTAZIDE 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 012616

Tradename:	ALDACTAZIDE
Applicant:	Pfizer
Ingredient:	hydrochlorothiazide; spironolactone
Patents:	0

Pharmacology for NDA: 012616

Mechanism of Action	Aldosterone Antagonists
Physiological Effect	Increased Diuresis

Suppliers and Packaging for NDA: 012616

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALDACTAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	012616	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1021	0025-1021-31	100 TABLET, FILM COATED in 1 BOTTLE (0025-1021-31)
ALDACTAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	012616	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-5014	59762-5014-1	100 TABLET, FILM COATED in 1 BOTTLE (59762-5014-1)

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;25MG
Approval Date:	Dec 30, 1982	TE:	AB	RLD:	Yes

Profile for product number 005

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG;50MG
Approval Date:	Dec 30, 1982	TE:		RLD:	Yes

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