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-three 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
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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