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Last Updated: July 25, 2024

Details for New Drug Application (NDA): 086513


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NDA 086513 describes SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ascot, Chartwell Rx, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, and Watson Labs, and is included in eight NDAs. It is available from four suppliers. Additional details are available on the SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE 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 086513
Pharmacology for NDA: 086513
Mechanism of ActionAldosterone Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 086513
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 086513 ANDA Mylan Pharmaceuticals Inc. 0378-0403 0378-0403-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0403-01)
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 086513 ANDA Mylan Pharmaceuticals Inc. 0378-0403 0378-0403-05 500 TABLET in 1 BOTTLE, PLASTIC (0378-0403-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;25MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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