Hydralazine hydrochloride; hydrochlorothiazide - Generic Drug Details

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

Hydralazine hydrochloride; hydrochlorothiazide is the generic ingredient in twenty-one branded drugs marketed by Novartis, Strides Pharma, Solvay, Superpharm, Watson Labs, Ivax Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Sandoz, Sun Pharm Industries, and Lederle, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

Sponsor	Phase
Vanderbilt University Medical Center	Phase 4
National Center for Research Resources (NCRR)	Phase 4
Vanderbilt University	Phase 1

Sponsor

Phase

Vanderbilt University Medical Center

Phase 4

National Center for Research Resources (NCRR)

Phase 4

Vanderbilt University

Phase 1

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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
Superpharm	HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	089200-001	Feb 9, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Solvay	HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	087609-001	Feb 8, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	HYDRA-ZIDE	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	088961-001	Oct 21, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Solvay	HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	087213-001	Feb 8, 1982		DISCN	No	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:	21
Applicants:	12
NDAs:	36
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
DailyMed Link:	hydralazine hydrochloride; hydrochlorothiazide at DailyMed