Details for New Drug Application (NDA): 203512
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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 203512
Tradename: | SPIRONOLACTONE |
Applicant: | Accord Hlthcare |
Ingredient: | spironolactone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203512
Mechanism of Action | Aldosterone Antagonists |
Medical Subject Heading (MeSH) Categories for 203512
Suppliers and Packaging for NDA: 203512
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SPIRONOLACTONE | spironolactone | TABLET;ORAL | 203512 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8178 | 0615-8178-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8178-05) |
SPIRONOLACTONE | spironolactone | TABLET;ORAL | 203512 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8178 | 0615-8178-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8178-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Sep 19, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Sep 19, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Sep 19, 2016 | TE: | AB | RLD: | No |
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