Assyro AI

FDA Orange Book · active-ingredient family

Hydralazine hydrochloride

Hydralazine hydrochloride is approved as 1 brand and 85 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:APRESOLINE · NDA 008303

1

Brand (NDA)

85

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, tablet

ProductApplicantApplicationTEApproved
APRESOLINERLD×5NOVARTISNDA 008303—Approved Prior to Jan 1, 1982

Generic (ANDA) products (85)

ProductApplicantApplicationTEApproved
HYDRALAZINE HYDROCHLORIDEBAXTER HLTHCARE CORPANDA 219797APJul 17, 2025
HYDRALAZINE HYDROCHLORIDEKINDOSANDA 217501APJun 02, 2025
HYDRALAZINE HYDROCHLORIDE×4MACLEODS PHARMS LTDANDA 211010—Aug 21, 2024
HYDRALAZINE HYDROCHLORIDEEUGIA PHARMAANDA 215147APFeb 13, 2023
HYDRALAZINE HYDROCHLORIDEHIKMAANDA 213667APDec 18, 2020
HYDRALAZINE HYDROCHLORIDE×4STRIDES PHARMAANDA 200770—Jun 25, 2019
HYDRALAZINE HYDROCHLORIDE×4RISINGANDA 209251—Jul 09, 2018
HYDRALAZINE HYDROCHLORIDE×4SCIEGEN PHARMSANDA 205236AAMay 26, 2017
HYDRALAZINE HYDROCHLORIDEPHARMOBEDIENTANDA 204680—Apr 28, 2016
HYDRALAZINE HYDROCHLORIDEPHARMOBEDIENTANDA 203110—Jun 29, 2015
HYDRALAZINE HYDROCHLORIDE×3CADILA PHARMS LTDANDA 203845AASep 18, 2014
HYDRALAZINE HYDROCHLORIDENAVINTA LLCANDA 202938APMar 28, 2013
HYDRALAZINE HYDROCHLORIDE×4ACTAVIS GRP PTCANDA 091679—Mar 04, 2013
HYDRALAZINE HYDROCHLORIDE×4ALKEM LABS LTDANDA 200737AADec 07, 2012
HYDRALAZINE HYDROCHLORIDE×4PHARMOBEDIENTANDA 090413—Dec 08, 2010
HYDRALAZINE HYDROCHLORIDE×4HERITAGE PHARMS INCANDA 040858AAFeb 26, 2010
HYDRALAZINE HYDROCHLORIDE×4HERITAGEANDA 086242—Feb 04, 2010
HYDRALAZINE HYDROCHLORIDE×4GLENMARK PHARMS LTDANDA 090527AAMay 29, 2009
HYDRALAZINE HYDROCHLORIDERISINGANDA 040730APApr 21, 2009
HYDRALAZINE HYDROCHLORIDE×4INVAGEN PHARMSANDA 090255—Dec 15, 2008
HYDRALAZINE HYDROCHLORIDE×4HETERO LABS LTD IIIANDA 040901AASep 12, 2008
HYDRALAZINE HYDROCHLORIDEFRESENIUS KABI USAANDA 040388APMar 13, 2001
HYDRALAZINE HYDROCHLORIDETEVA PARENTERALANDA 040373—Feb 23, 2000
HYDRALAZINE HYDROCHLORIDEAM REGENTANDA 040136APJun 30, 1997
HYDRALAZINE HYDROCHLORIDEABRAXIS PHARMANDA 089532—Aug 11, 1987
HYDRALAZINE HYDROCHLORIDETP ANDA HOLDINGSANDA 089359—Jul 25, 1986
HYDRALAZINE HYDROCHLORIDETP ANDA HOLDINGSANDA 089258—May 05, 1986
HYDRALAZINE HYDROCHLORIDETP ANDA HOLDINGSANDA 089259—May 05, 1986
HYDRALAZINE HYDROCHLORIDEHALSEYANDA 089218—Jan 22, 1986
HYDRALAZINE HYDROCHLORIDEHALSEYANDA 089222—Jan 22, 1986
HYDRALAZINE HYDROCHLORIDEHALSEYANDA 089130—Jan 15, 1986
HYDRALAZINE HYDROCHLORIDEHALSEYANDA 089178—Jan 15, 1986
HYDRALAZINE HYDROCHLORIDEPLIVAANDA 089097AADec 18, 1985
HYDRALAZINE HYDROCHLORIDEPLIVAANDA 089098AADec 18, 1985
HYDRALAZINE HYDROCHLORIDESOLOPAKANDA 088517—Aug 22, 1985
HYDRALAZINE HYDROCHLORIDEMUTUAL PHARMANDA 088728—Apr 11, 1985
HYDRALAZINE HYDROCHLORIDETP ANDA HOLDINGSANDA 088729—Apr 11, 1985
HYDRALAZINE HYDROCHLORIDECHARTWELL RXANDA 088846—Feb 26, 1985
HYDRALAZINE HYDROCHLORIDECHARTWELL RXANDA 088847—Feb 26, 1985
HYDRALAZINE HYDROCHLORIDECHARTWELL RXANDA 088848—Feb 26, 1985
HYDRALAZINE HYDROCHLORIDECHARTWELL RXANDA 088849—Feb 26, 1985
HYDRALAZINE HYDROCHLORIDEASCOTANDA 088310—Dec 19, 1984
HYDRALAZINE HYDROCHLORIDEASCOTANDA 088311—Dec 19, 1984
HYDRALAZINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 088649—Oct 18, 1984
HYDRALAZINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 088560—Oct 04, 1984
HYDRALAZINE HYDROCHLORIDESUPERPHARMANDA 088787—Aug 28, 1984
HYDRALAZINE HYDROCHLORIDESUPERPHARMANDA 088788—Aug 28, 1984
HYDRALAZINE HYDROCHLORIDESUPERPHARMANDA 088789—Aug 28, 1984
HYDRALAZINE HYDROCHLORIDEQUANTUM PHARMICSANDA 088657—Jun 15, 1984
HYDRALAZINE HYDROCHLORIDEQUANTUM PHARMICSANDA 088652—May 08, 1984
HYDRALAZINE HYDROCHLORIDERLDPLIVAANDA 088467AAMay 01, 1984
HYDRALAZINE HYDROCHLORIDERLDPLIVAANDA 088468AAMay 01, 1984
HYDRALAZINE HYDROCHLORIDEQUANTUM PHARMICSANDA 088671—May 01, 1984
HYDRALAZINE HYDROCHLORIDEQUANTUM PHARMICSANDA 088686—May 01, 1984
HYDRALAZINE HYDROCHLORIDESMITH AND NEPHEWANDA 088518—Apr 20, 1984
HYDRALAZINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 088391—Sep 27, 1983
HYDRALAZINE HYDROCHLORIDEPUREPAC PHARMANDA 088178—Aug 15, 1983
HYDRALAZINE HYDROCHLORIDEPUREPAC PHARMANDA 088177—Jul 29, 1983
HYDRALAZINE HYDROCHLORIDEWEST WARDANDA 088240—May 27, 1983
HYDRALAZINE HYDROCHLORIDEWEST WARDANDA 088241—May 27, 1983
HYDRALAZINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 087836—Oct 05, 1982
HYDRALAZINE HYDROCHLORIDEWATSON LABSANDA 085533—May 25, 1982
HYDRALAZINE HYDROCHLORIDEWATSON LABSANDA 085532—May 24, 1982
HYDRALAZINE HYDROCHLORIDEVANGARDANDA 087908—May 07, 1982
HYDRALAZINE HYDROCHLORIDEUSL PHARMAANDA 087780—Mar 29, 1982
HYDRALAZINE HYDROCHLORIDEUSL PHARMAANDA 087751—Mar 29, 1982
DRALZINETEVAANDA 084301—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEIMPAX LABSANDA 084922—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEIMPAX LABSANDA 084923—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084443—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084437—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084469—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084581—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEMUTUAL PHARMANDA 084106—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEMUTUAL PHARMANDA 084107—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 086961—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 086962—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEUPSHER SMITH LABSANDA 083241—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEUPSHER SMITH LABSANDA 083560—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEUPSHER SMITH LABSANDA 083561—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEUPSHER SMITH LABSANDA 085088—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEVANGARDANDA 087712—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEVITARINEANDA 086088—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEWATSON LABSANDA 084504—Approved Prior to Jan 1, 1982
HYDRALAZINE HYDROCHLORIDEWATSON LABSANDA 084503—Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Hydralazine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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