FDA Orange Book · active-ingredient family
Hydralazine hydrochloride
Hydralazine hydrochloride: 1 brand, 85 generics; first approved Mar 29, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 85 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
85
Listed patents
0
Presentations
128
Brand (NDA) products
Originator applications
- APRESOLINERLDNOVARTISNDA 008303-5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - 50MG TABLET ORAL Discontinued - 20MG/ML INJECTABLE INJECTION Discontinued - 10MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued -
Generic (ANDA) products (85)
Abbreviated applications
- HYDRALAZINE HYDROCHLORIDEBAXTER HLTHCARE CORPANDA 2197972025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - HYDRALAZINE HYDROCHLORIDEKINDOSANDA 2175012025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - HYDRALAZINE HYDROCHLORIDEMACLEODS PHARMSANDA 21101020244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEEUGIA PHARMAANDA 2151472023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - HYDRALAZINE HYDROCHLORIDEHIKMAANDA 2136672020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - HYDRALAZINE HYDROCHLORIDESTRIDES PHARMAANDA 20077020194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AA 50MG TABLET ORAL Rx AA 100MG TABLET ORAL Rx AA 10MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDERISINGANDA 20925120184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDESCIEGEN PHARMSANDA 20523620174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA 50MG TABLET ORAL Rx AA 100MG TABLET ORAL Rx AA - HYDRALAZINE HYDROCHLORIDEPHARMOBEDIENTANDA 2046802016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued - - HYDRALAZINE HYDROCHLORIDEPHARMOBEDIENTANDA 2031102015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued - - HYDRALAZINE HYDROCHLORIDECADILA PHARMS LTDANDA 20384520143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AA 50MG TABLET ORAL Rx AA 100MG TABLET ORAL Rx AA - HYDRALAZINE HYDROCHLORIDENAVINTA LLCANDA 2029382013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - HYDRALAZINE HYDROCHLORIDEACTAVIS GRP PTCANDA 09167920134 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEALKEM LABS LTDANDA 20073720124 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA 50MG TABLET ORAL Rx AA 100MG TABLET ORAL Rx AA - HYDRALAZINE HYDROCHLORIDEPHARMOBEDIENTANDA 09041320104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEHERITAGE PHARMS INCANDA 04085820104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA 50MG TABLET ORAL Rx AA 100MG TABLET ORAL Rx AA - HYDRALAZINE HYDROCHLORIDEHERITAGEANDA 08624220104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - 50MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEGLENMARK PHARMS LTDANDA 09052720094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA 50MG TABLET ORAL Rx AA 100MG TABLET ORAL Rx AA - HYDRALAZINE HYDROCHLORIDERISINGANDA 0407302009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - HYDRALAZINE HYDROCHLORIDEINVAGEN PHARMSANDA 09025520084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEHETERO LABS LTD IIIANDA 04090120084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA 50MG TABLET ORAL Rx AA 100MG TABLET ORAL Rx AA - HYDRALAZINE HYDROCHLORIDERSFRESENIUS KABI USAANDA 0403882001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - HYDRALAZINE HYDROCHLORIDETEVA PARENTERALANDA 0403732000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued - - HYDRALAZINE HYDROCHLORIDEAM REGENTANDA 0401361997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - HYDRALAZINE HYDROCHLORIDEABRAXIS PHARMANDA 0895321987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued - - HYDRALAZINE HYDROCHLORIDETP ANDA HOLDINGSANDA 0893591986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDETP ANDA HOLDINGSANDA 0892581986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDETP ANDA HOLDINGSANDA 0892591986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEHALSEYANDA 0892181986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEHALSEYANDA 0892221986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEHALSEYANDA 0891301986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEHALSEYANDA 0891781986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDERSPLIVAANDA 0890971985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AA - HYDRALAZINE HYDROCHLORIDERSPLIVAANDA 0890981985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AA - HYDRALAZINE HYDROCHLORIDESOLOPAKANDA 0885171985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued - - HYDRALAZINE HYDROCHLORIDEMUTUAL PHARMANDA 0887281985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDETP ANDA HOLDINGSANDA 0887291985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDECHARTWELL RXANDA 0888461985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDECHARTWELL RXANDA 0888471985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDECHARTWELL RXANDA 0888481985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDECHARTWELL RXANDA 0888491985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEASCOTANDA 0883101984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEASCOTANDA 0883111984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 0886491984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 0885601984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDESUPERPHARMANDA 0887871984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDESUPERPHARMANDA 0887881984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDESUPERPHARMANDA 0887891984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEQUANTUM PHARMICSANDA 0886571984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEQUANTUM PHARMICSANDA 0886521984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDERLDRSPLIVAANDA 0884671984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AA - HYDRALAZINE HYDROCHLORIDERLDRSPLIVAANDA 0884681984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AA - HYDRALAZINE HYDROCHLORIDEQUANTUM PHARMICSANDA 0886711984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEQUANTUM PHARMICSANDA 0886861984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDESMITH AND NEPHEWANDA 0885181984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued - - HYDRALAZINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 0883911983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEPUREPAC PHARMANDA 0881781983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEPUREPAC PHARMANDA 0881771983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEWEST WARDANDA 0882401983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEWEST WARDANDA 0882411983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 0878361982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEWATSON LABSANDA 0855331982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEWATSON LABSANDA 0855321982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEVANGARDANDA 0879081982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEUSL PHARMAANDA 0877801982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEUSL PHARMAANDA 0877511982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - TEVAANDA 084301-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEIMPAX LABSANDA 084922-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEIMPAX LABSANDA 084923-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084443-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084437-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084469-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084581-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEMUTUAL PHARMANDA 084106-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEMUTUAL PHARMANDA 084107-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 086961-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 086962-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEUPSHER SMITH LABSANDA 083241-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEUPSHER SMITH LABSANDA 083560-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEUPSHER SMITH LABSANDA 083561-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEUPSHER SMITH LABSANDA 085088-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEVANGARDANDA 087712-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEVITARINEANDA 086088-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEWATSON LABSANDA 084504-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - HYDRALAZINE HYDROCHLORIDEWATSON LABSANDA 084503-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued -
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
45 yr 3 mo ago
Most recent approval
1 yr 4 mo ago
Approvals span 1982–2025 across 86 FDA applications.
Brand (NDA) 11%
Generic (ANDA) 8599%
Hydralazine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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