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Last Updated: May 19, 2024

Details for New Drug Application (NDA): 012151

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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-one suppliers are listed for this compound. Additional details are available on the spironolactone profile page.
Summary for 012151
Formulation / Manufacturing:see details
Pharmacology for NDA: 012151
Mechanism of ActionAldosterone Antagonists
Medical Subject Heading (MeSH) Categories for 012151
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:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 30, 1982TE:ABRLD:Yes

Profile for product number 009

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Dec 30, 1983TE:ABRLD:Yes

Profile for product number 010

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 30, 1983TE:ABRLD:Yes

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