Details for New Drug Application (NDA): 086513

NDA 086513 describes SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ascot, Chartwell Rx, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, and Watson Labs, and is included in eight NDAs. It is available from three suppliers. Additional details are available on the SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE 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 086513

Tradename:	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Applicant:	Mylan
Ingredient:	hydrochlorothiazide; spironolactone
Patents:	0

Pharmacology for NDA: 086513

Mechanism of Action	Aldosterone Antagonists
Physiological Effect	Increased Diuresis

Suppliers and Packaging for NDA: 086513

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	086513	ANDA	Mylan Pharmaceuticals Inc.	0378-0403	0378-0403-01	100 TABLET in 1 BOTTLE, PLASTIC (0378-0403-01)
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	086513	ANDA	Mylan Pharmaceuticals Inc.	0378-0403	0378-0403-05	500 TABLET in 1 BOTTLE, PLASTIC (0378-0403-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	No

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