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Generated: April 26, 2017

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Spironolactone - Generic Drug Details

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What are the generic sources for spironolactone and what is the scope of freedom to operate?

is the generic ingredient in two branded drugs marketed by Ivax Pharms, Sandoz, Accord Hlthcare, 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. There is one patent protecting this compound. 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 list6,111
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gd Searle Llc
TABLET;ORAL012151-010Dec 30, 1983ABRXYesYes► Subscribe► Subscribe
TABLET;ORAL040750-002Aug 29, 2006ABRXNoNo► Subscribe► Subscribe
Amneal Pharms
TABLET;ORAL091426-002Jun 8, 2010ABRXNoNo► Subscribe► Subscribe
Orion Corp Orion
TABLET;ORAL202187-002Mar 6, 2014ABRXNoNo► Subscribe► Subscribe
Accord Hlthcare
TABLET;ORAL203512-003Sep 19, 2016ABRXNoNo► Subscribe► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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