Details for New Drug Application (NDA): 205936
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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 205936
Tradename: | SPIRONOLACTONE |
Applicant: | Zydus Pharms |
Ingredient: | spironolactone |
Patents: | 0 |
Pharmacology for NDA: 205936
Mechanism of Action | Aldosterone Antagonists |
Medical Subject Heading (MeSH) Categories for 205936
Suppliers and Packaging for NDA: 205936
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SPIRONOLACTONE | spironolactone | TABLET;ORAL | 205936 | ANDA | Major Pharmaceuticals | 0904-6927 | 0904-6927-61 | 100 BLISTER PACK in 1 CARTON (0904-6927-61) / 1 TABLET in 1 BLISTER PACK |
SPIRONOLACTONE | spironolactone | TABLET;ORAL | 205936 | ANDA | Northwind Pharmaceuticals, LLC | 51655-153 | 51655-153-26 | 90 TABLET in 1 BOTTLE, PLASTIC (51655-153-26) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 18, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 18, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Jul 18, 2018 | TE: | AB | RLD: | No |
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