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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
QuintilesIMS
Covington
Accenture
Healthtrust
US Army
Express Scripts
Argus Health

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089424

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NDA 089424 describes SPIRONOLACTONE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma Ltd, Casi Pharms Inc, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Vintage, Warner Chilcott, Watson Labs, Yaopharma Co Ltd, 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-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.
Summary for 089424
Tradename:SPIRONOLACTONE
Applicant:Sun Pharm Industries
Ingredient:spironolactone
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 089424
Mechanism of ActionAldosterone Antagonists
Medical Subject Heading (MeSH) Categories for 089424
Suppliers and Packaging for NDA: 089424
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRONOLACTONE spironolactone TABLET;ORAL 089424 ANDA Rebel Distributors Corp 21695-766 E 21695-766-30
SPIRONOLACTONE spironolactone TABLET;ORAL 089424 ANDA A-S Medication Solutions 50090-0136 N 50090-0136-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jul 23, 1986TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 11, 1999TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 11, 1999TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Colorcon
UBS
McKesson
Deloitte
Daiichi Sankyo
Merck
Baxter
AstraZeneca

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