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Mallinckrodt
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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203253

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NDA 203253 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-one 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 203253
Tradename:SPIRONOLACTONE
Applicant:Jubilant Generics
Ingredient:spironolactone
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203253
Mechanism of ActionAldosterone Antagonists
Medical Subject Heading (MeSH) Categories for 203253
Suppliers and Packaging for NDA: 203253
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRONOLACTONE spironolactone TABLET;ORAL 203253 ANDA Aidarex Pharmaceuticals LLC 53217-240 N 53217-240-30
SPIRONOLACTONE spironolactone TABLET;ORAL 203253 ANDA Aidarex Pharmaceuticals LLC 53217-240 N 53217-240-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Apr 23, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Apr 23, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Apr 23, 2014TE:ABRLD:No

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Healthtrust
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Farmers Insurance
Daiichi Sankyo
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QuintilesIMS
Cantor Fitzgerald
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Harvard Business School

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