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 Medical Center	Phase 1

Sponsor

Phase

Vanderbilt University Medical Center

Phase 4

National Center for Research Resources (NCRR)

Phase 4

Vanderbilt University Medical Center

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
Watson Labs	HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	085440-001	Mar 4, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Pharms	HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	088356-001	Apr 10, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Solvay	SER-A-GEN	hydralazine hydrochloride; hydrochlorothiazide; reserpine	TABLET;ORAL	087210-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE	hydralazine hydrochloride; hydrochlorothiazide; reserpine	TABLET;ORAL	087085-001	Approved Prior to Jan 1, 1982		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
Watson Labs	HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE	hydralazine hydrochloride; hydrochlorothiazide; reserpine	TABLET;ORAL	083770-001	Approved Prior to Jan 1, 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