Details for New Drug Application (NDA): 012151
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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 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 012151
Mechanism of Action | Aldosterone 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: | 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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