Details for New Drug Application (NDA): 012151

NDA 012151 describes ALDACTONE, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the ALDACTONE profile page.

The generic ingredient in ALDACTONE is spironolactone. There are sixteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the spironolactone profile page.

Summary for 012151

Tradename:	ALDACTONE
Applicant:	Pfizer
Ingredient:	spironolactone
Patents:	0

Pharmacology for NDA: 012151

Mechanism of Action

Aldosterone Antagonists

Medical Subject Heading (MeSH) Categories for 012151

Diuretics

Mineralocorticoid Receptor Antagonists

Suppliers and Packaging for NDA: 012151

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALDACTONE	spironolactone	TABLET;ORAL	012151	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1001	0025-1001-31	100 TABLET, FILM COATED in 1 BOTTLE (0025-1001-31)
ALDACTONE	spironolactone	TABLET;ORAL	012151	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1031	0025-1031-31	100 TABLET, FILM COATED in 1 BOTTLE (0025-1031-31)

Profile for product number 008

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

Profile for product number 009

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Dec 30, 1983	TE:	AB	RLD:	Yes

Profile for product number 010

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Dec 30, 1983	TE:	AB	RLD:	Yes

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