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Last Updated: May 14, 2021

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, Chartwell Rx, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Oxford Pharms, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, Zydus Pharms, Yaopharma Co Ltd, Parke Davis, and Usl Pharma, and is included in forty NDAs. It is available from thirty-five 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
Applicant:Jubilant Generics
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 QPharma Inc 42708-101 42708-101-30 30 TABLET, FILM COATED in 1 BOTTLE (42708-101-30)
SPIRONOLACTONE spironolactone TABLET;ORAL 203253 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-216 59746-216-01 100 TABLET, FILM COATED in 1 BOTTLE (59746-216-01)

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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