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Serving hundreds of leading biopharmaceutical companies globally:

Generated: June 24, 2018

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, 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 040750

Tradename:	SPIRONOLACTONE
Applicant:	Vintage
Ingredient:	spironolactone
Patents:	0
Therapeutic Class:	Cardiovascular Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 040750

Mechanism of Action	Aldosterone Antagonists

Medical Subject Heading (MeSH) Categories for 040750

Diuretics
Mineralocorticoid Receptor Antagonists

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	N	0603-5763-21
SPIRONOLACTONE	spironolactone	TABLET;ORAL	040750	ANDA	Par Pharmaceutical	0603-5763	N	0603-5763-28

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Aug 29, 2006	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Aug 29, 2006	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Aug 29, 2006	TE:	AB	RLD:	No

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