Details for New Drug Application (NDA): 040750
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The generic ingredient in SPIRONOLACTONE 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 040750
Tradename: | SPIRONOLACTONE |
Applicant: | Oxford Pharms |
Ingredient: | spironolactone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040750
Mechanism of Action | Aldosterone Antagonists |
Medical Subject Heading (MeSH) Categories for 040750
Suppliers and Packaging for NDA: 040750
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SPIRONOLACTONE | spironolactone | TABLET;ORAL | 040750 | ANDA | A-S Medication Solutions | 50090-6369 | 50090-6369-0 | 100 TABLET, COATED in 1 BOTTLE (50090-6369-0) |
SPIRONOLACTONE | spironolactone | TABLET;ORAL | 040750 | ANDA | A-S Medication Solutions | 50090-6369 | 50090-6369-1 | 30 TABLET, COATED in 1 BOTTLE (50090-6369-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Aug 29, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Aug 29, 2006 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 29, 2006 | TE: | AB | RLD: | No |
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