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Last Updated: October 12, 2024

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE - Generic Drug Details


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

Hydralazine hydrochloride; hydrochlorothiazide; reserpine is the generic ingredient in twelve branded drugs marketed by Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Watson Labs, Sandoz, Solvay, Sun Pharm Industries, Lederle, and Novartis, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

Summary for HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
US Patents:0
Tradenames:12
Applicants:9
NDAs:16
Clinical Trials: 1
DailyMed Link:HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE at DailyMed
Recent Clinical Trials for HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

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

SponsorPhase
VA Office of Research and Development
US Department of Veterans Affairs

See all HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE clinical trials

US Patents and Regulatory Information for HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Novartis SER-AP-ES hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 012193-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Solvay UNIPRES hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 086298-001 Approved Prior to Jan 1, 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
Watson Labs RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 087556-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lederle RESERPINE, HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 087709-001 May 13, 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

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