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Last Updated: October 24, 2020

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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, 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
Recent Clinical Trials for hydralazine hydrochloride; hydrochlorothiazide

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

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

See all hydralazine hydrochloride; hydrochlorothiazide clinical trials

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
Sandoz HYDRAP-ES hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 084876-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Par Pharm HYDRA-ZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 088957-001 Oct 21, 1985 RX No No   Start Trial   Start Trial   Start Trial
Ivax Pharms HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 088358-001 Apr 10, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis APRESAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 084811-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Par Pharm HYDRA-ZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 088946-001 Oct 21, 1985 RX No Yes   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 084291-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
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   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Medtronic
Mallinckrodt
Johnson and Johnson
Dow

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