Details for New Drug Application (NDA): 089424
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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 089424
Tradename: | SPIRONOLACTONE |
Applicant: | Sun Pharm Industries |
Ingredient: | spironolactone |
Patents: | 0 |
Pharmacology for NDA: 089424
Mechanism of Action | Aldosterone Antagonists |
Medical Subject Heading (MeSH) Categories for 089424
Suppliers and Packaging for NDA: 089424
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SPIRONOLACTONE | spironolactone | TABLET;ORAL | 089424 | ANDA | NorthStar Rx LLC | 16714-084 | 16714-084-01 | 100 TABLET in 1 BOTTLE, PLASTIC (16714-084-01) |
SPIRONOLACTONE | spironolactone | TABLET;ORAL | 089424 | ANDA | NorthStar Rx LLC | 16714-084 | 16714-084-02 | 500 TABLET in 1 BOTTLE, PLASTIC (16714-084-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 23, 1986 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Aug 11, 1999 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 11, 1999 | TE: | AB | RLD: | No |
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