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Spironolactone - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for spironolactone?

Spironolactone is the generic ingredient in two branded drugs marketed by Ivax Pharms, Sandoz, Accord Hlthcare Inc, Mylan, Sun Pharm Inds, Amneal Pharms, Lederle, Vangard, Vintage, Gd Searle Llc, Warner Chilcott, Actavis Elizabeth, Jubilant Generics, Purepac Pharm, Upsher Smith, Superpharm, Mutual Pharm, Watson Labs, Ascot, and Orion Corp Orion, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for spironolactone. Forty suppliers are listed for this compound.

Summary for Generic Name: spironolactone

Drug Master File Entries: see list15
Suppliers / Packagers: see list40
Bulk Api Vendors: see list45
Clinical Trials: see list38
Patent Applications: see list6,095
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:spironolactone at DailyMed

Pharmacology for Ingredient: spironolactone

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orion Corp Orion
TABLET;ORAL202187-001Mar 6, 2014RXNoNo► Subscribe► Subscribe
TABLET;ORAL040424-002Aug 20, 2001RXNoNo► Subscribe► Subscribe
Upsher Smith
TABLET;ORAL087554-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Watson Labs
TABLET;ORAL087078-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Purepac Pharm
TABLET;ORAL088053-001Aug 25, 1983DISCNNoNo► Subscribe► Subscribe
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