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Last Updated: December 9, 2019

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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
National Center for Research Resources (NCRR)Phase 4
Vanderbilt University Medical CenterPhase 4
Vanderbilt University Medical CenterPhase 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   Start Trial   Start Trial   Start Trial
Solvay UNIPRES hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 086298-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Solvay SER-A-GEN hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 087210-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Solvay HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 087213-001 Feb 8, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Superpharm HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 089200-001 Feb 9, 1987 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:

Express Scripts
Johnson and Johnson
Medtronic
Boehringer Ingelheim
Mallinckrodt
Dow

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