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Last Updated: August 11, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091426

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NDA 091426 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-four 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 091426
Applicant:Amneal Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 091426
Mechanism of ActionAldosterone Antagonists
Medical Subject Heading (MeSH) Categories for 091426
Suppliers and Packaging for NDA: 091426
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRONOLACTONE spironolactone TABLET;ORAL 091426 ANDA QPharma Inc 42708-126 42708-126-30 30 TABLET in 1 BOTTLE (42708-126-30)
SPIRONOLACTONE spironolactone TABLET;ORAL 091426 ANDA Amneal Pharmaceuticals of New York LLC 53746-511 53746-511-01 100 TABLET in 1 BOTTLE (53746-511-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jul 2, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 2, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jul 2, 2010TE:ABRLD:No

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