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FDA Orange Book ยท active-ingredient family

Hydroxyzine hydrochloride

Hydroxyzine hydrochloride: 3 brands, 104 generics; first approved Jan 22, 1982; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 104 ANDA applications approved.

Brands (NDA)
3
Generics (ANDA)
104
Listed patents
0
Presentations
146

Brand (NDA) products

Originator applications
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  • NDA 011111-2 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • NDA 010392-4 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
    25MGTABLETORALDiscontinued-
    100MGTABLETORALDiscontinued-
    50MGTABLETORALDiscontinued-
  • NDA 010485-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/5MLSYRUPORALDiscontinued-

Generic (ANDA) products (104)

Abbreviated applications
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  • HYDROXYZINE HYDROCHLORIDE
    ANDA 2202712026
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/5MLSYRUPORALRxAA
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 2196482025
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/5MLSYRUPORALRxAA
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 2192892025
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/5MLSYRUPORALRxAA
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 21765220233 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALRxAB
    25MGTABLETORALRxAB
    50MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 2106342019
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/5MLSYRUPORALRxAA
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 20712120173 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALRxAB
    10MGTABLETORALRxAB
    50MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 20427920143 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALRxAB
    25MGTABLETORALRxAB
    50MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 2016742013
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/5MLSYRUPORALRxAA
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 09117620103 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
    25MGTABLETORALDiscontinued-
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 04080820083 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
    25MGTABLETORALDiscontinued-
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 04080420083 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALRxAB
    25MGTABLETORALRxAB
    50MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 04089920083 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
    25MGTABLETORALDiscontinued-
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 04080520083 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALRxAB
    25MGTABLETORALRxAB
    50MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 04084020083 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALRxAB
    10MGTABLETORALRxAB
    25MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 04081220083 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
    25MGTABLETORALDiscontinued-
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 04078620073 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALRxAB
    25MGTABLETORALRxAB
    50MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 04058020053 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALRxAB
    25MGTABLETORALRxAB
    10MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 04060420043 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALRxAB
    10MGTABLETORALRxAB
    25MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0405592004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0405622004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0405632004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0403912002
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/5MLSYRUPORALRxAA
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0810541995
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    100MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0400101994
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/5MLSYRUPORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0811491994
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0811501994
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0811511994
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0893661988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0891171988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0893961988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0887851988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/5MLSYRUPORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0890711986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0890721986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0890731986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0893811986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0893821986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0893831986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0891211986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0891221986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0891231986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0888621986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0891061986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0888811986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0891071986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDERLDRS
    ANDA 0886171986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDERLDRS
    ANDA 0886181986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDERLD
    ANDA 0886191986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0885401985
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0885511985
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0885291985
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0887941984
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0887951984
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0887961984
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0881201984
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0881211984
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0881221984
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0884091983
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0883481983
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0883491983
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0883501983
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0878571983
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0878601983
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0878621983
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    100MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0881841983
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0881851983
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 08787119823 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALRxAB
    10MGTABLETORALRxAB
    25MGTABLETORALRxAB
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0877301982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/5MLSYRUPORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0878191982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0878201982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0878211982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0878221982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    100MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 08727319822 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDERLDRS
    ANDA 0872941982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/5MLSYRUPORALRxAA
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0876021982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 0876031982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDERLD
    ANDA 0876041982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • ANDA 085551-2 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDERLDRS
    ANDA 087408-2 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONRx-
    50MG/MLINJECTABLEINJECTIONRx-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 085779-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087329-2 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087416-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 086821-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087546-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087592-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 086822-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087591-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087310-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087593-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087595-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087596-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 085778-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087274-2 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 086258-2 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • ANDA 087014-2 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG/MLINJECTABLEINJECTIONDiscontinued-
    50MG/MLINJECTABLEINJECTIONDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 086880-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/5MLSYRUPORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087216-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087410-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087411-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087246-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 085247-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 087245-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 086827-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 086829-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MGTABLETORALDiscontinued-
  • HYDROXYZINE HYDROCHLORIDE
    ANDA 086836-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    50MGTABLETORALDiscontinued-

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
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First approval
45 yr 5 mo ago
Most recent approval
4 mo ago

Approvals span 1982โ€“2026 across 107 FDA applications.

Brand (NDA) 33%
Generic (ANDA) 10497%

Hydroxyzine 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.

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