Details for New Drug Application (NDA): 215572
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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 215572
Tradename: | SPIRONOLACTONE |
Applicant: | Amneal |
Ingredient: | spironolactone |
Patents: | 0 |
Pharmacology for NDA: 215572
Mechanism of Action | Aldosterone Antagonists |
Medical Subject Heading (MeSH) Categories for 215572
Suppliers and Packaging for NDA: 215572
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SPIRONOLACTONE | spironolactone | SUSPENSION;ORAL | 215572 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-2028 | 17856-2028-3 | 60 SYRINGE in 1 PACKAGE (17856-2028-3) / 10 SYRINGE in 1 SYRINGE (17856-2028-2) / 2.5 mL in 1 SYRINGE (17856-2028-1) |
SPIRONOLACTONE | spironolactone | SUSPENSION;ORAL | 215572 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2027 | 69238-2027-2 | 473 mL in 1 BOTTLE (69238-2027-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/5ML | ||||
Approval Date: | Sep 5, 2023 | TE: | AB | RLD: | No |
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