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Hydralazine hydrochloride; hydrochlorothiazide - Generic Drug Details

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What are the generic drug sources for hydralazine hydrochloride; hydrochlorothiazide and what is the scope of patent protection?

Hydralazine hydrochloride; hydrochlorothiazide is the generic ingredient in twenty-one branded drugs marketed by Novartis, Par Pharm, 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.

There are twenty-one drug master file entries for hydralazine hydrochloride; hydrochlorothiazide.

Summary for hydralazine hydrochloride; hydrochlorothiazide

US Patents:	0
Tradenames:	21
Applicants:	12
NDAs:	36
Drug Master File Entries:	21
Bulk Api Vendors:	1
Clinical Trials:	3
DailyMed Link:	hydralazine hydrochloride; hydrochlorothiazide at DailyMed

Recent Clinical Trials for hydralazine hydrochloride; hydrochlorothiazide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Center for Research Resources (NCRR)	Phase 4
Vanderbilt University Medical Center	Phase 4
Vanderbilt University Medical Center	Phase 1/Phase 2

See all hydralazine hydrochloride; hydrochlorothiazide clinical trials

Synonyms for hydralazine hydrochloride; hydrochlorothiazide

C8H8N4.C7H8ClN3O4S2.HCl

LS-178474

SCHEMBL9374288

US Patents and Regulatory Information for hydralazine hydrochloride; hydrochlorothiazide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lederle	RESERPINE, HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; hydrochlorothiazide; reserpine	TABLET;ORAL	087709-001	May 13, 1982		DISCN	No	No
Solvay	UNIPRES	hydralazine hydrochloride; hydrochlorothiazide; reserpine	TABLET;ORAL	085893-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ivax Sub Teva Pharms	HYDROSERPINE PLUS (R-H-H)	hydralazine hydrochloride; hydrochlorothiazide; reserpine	TABLET;ORAL	083877-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell Rx	CAM-AP-ES	hydralazine hydrochloride; hydrochlorothiazide; reserpine	TABLET;ORAL	084897-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Superpharm	HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	089201-001	Feb 9, 1987		DISCN	No	No
Watson Labs	HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	085457-001	Mar 4, 1982		DISCN	No	No
Superpharm	HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	089200-001	Feb 9, 1987		DISCN	No	No