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Last Updated: August 14, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040750

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NDA 040750 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 040750
Tradename:SPIRONOLACTONE
Applicant:Oxford Pharms
Ingredient:spironolactone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040750
Mechanism of ActionAldosterone Antagonists
Medical Subject Heading (MeSH) Categories for 040750
Suppliers and Packaging for NDA: 040750
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRONOLACTONE spironolactone TABLET;ORAL 040750 ANDA Par Pharmaceutical 0603-5763 0603-5763-21 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5763-21)
SPIRONOLACTONE spironolactone TABLET;ORAL 040750 ANDA Par Pharmaceutical 0603-5763 0603-5763-28 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5763-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Aug 29, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 29, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 29, 2006TE:ABRLD:No

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