Details for New Drug Application (NDA): 091426
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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 091426
Tradename: | SPIRONOLACTONE |
Applicant: | Amneal Pharms |
Ingredient: | spironolactone |
Patents: | 0 |
Pharmacology for NDA: 091426
Mechanism of Action | Aldosterone Antagonists |
Medical Subject Heading (MeSH) Categories for 091426
Suppliers and Packaging for NDA: 091426
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SPIRONOLACTONE | spironolactone | TABLET;ORAL | 091426 | ANDA | QPharma, Inc. | 42708-126 | 42708-126-30 | 30 TABLET in 1 BOTTLE (42708-126-30) |
SPIRONOLACTONE | spironolactone | TABLET;ORAL | 091426 | ANDA | A-S Medication Solutions | 50090-1292 | 50090-1292-0 | 100 TABLET in 1 BOTTLE (50090-1292-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 2, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 2, 2010 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Jul 2, 2010 | TE: | AB | RLD: | No |
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