Hydrochlorothiazide; spironolactone - Generic Drug Details

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What are the generic sources for hydrochlorothiazide; spironolactone and what is the scope of freedom to operate?

Hydrochlorothiazide; spironolactone is the generic ingredient in three branded drugs marketed by Pfizer, Ascot, Chartwell Rx, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, Watson Labs, Ivax Pharms, Lederle, Parke Davis, Upsher Smith, Usl Pharma, and Vangard, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

Seven suppliers are listed for this compound.

Sponsor	Phase
Chiang Mai University	Phase 3
Medical University of Bialystok	N/A
Shanghai Jiao Tong University School of Medicine	Phase 4

Sponsor

Phase

Chiang Mai University

Phase 3

Medical University of Bialystok

N/A

Shanghai Jiao Tong University School of Medicine

Phase 4

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087398-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Superpharm	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	089137-001	Aug 26, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	086513-001	Approved Prior to Jan 1, 1982	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	089534-001	Jul 2, 1987	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	ALDACTAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	012616-005	Dec 30, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	18
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	9
DailyMed Link:	hydrochlorothiazide; spironolactone at DailyMed

Drug Class	Aldosterone Antagonist Thiazide Diuretic
Mechanism of Action	Aldosterone Antagonists
Physiological Effect	Increased Diuresis