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BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Chubb
Julphar
Daiichi Sankyo
Cantor Fitzgerald
AstraZeneca
US Department of Justice
Chinese Patent Office
Merck
Accenture
Covington

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086809

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NDA 086809 describes SPIRONOLACTONE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Orion Corp Orion, Purepac Pharm, Sandoz, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Vintage, Warner Chilcott, Watson Labs, Parke Davis, and Usl Pharma, and is included in thirty-nine NDAs. It is available from forty suppliers. Additional details are available on the SPIRONOLACTONE profile page.

The generic ingredient in SPIRONOLACTONE is hydrochlorothiazide; spironolactone. There are thirty-one 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 086809

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 086809

Mechanism of ActionAldosterone Antagonists

Suppliers and Packaging for NDA: 086809

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRONOLACTONE spironolactone TABLET;ORAL 086809 ANDA Sandoz Inc 0781-1599 0781-1599-05 500 TABLET, FILM COATED in 1 BOTTLE (0781-1599-05)
SPIRONOLACTONE spironolactone TABLET;ORAL 086809 ANDA Sandoz Inc 0781-1599 0781-1599-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-1599-01)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Fish and Richardson
Boehringer Ingelheim
Cipla
McKesson
Dow
Queensland Health
Argus Health
Farmers Insurance

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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