Assyro AI

FDA Orange Book · active-ingredient family

Hydroxyzine hydrochloride

Hydroxyzine hydrochloride is approved as 3 brand and 104 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VISTARIL · NDA 011111

3

Brand (NDA)

104

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, syrup, tablet

ProductApplicantApplicationTEApproved
VISTARILRLD×2PFIZERNDA 011111—Approved Prior to Jan 1, 1982
ATARAXRLD×4PFIZERNDA 010392—Approved Prior to Jan 1, 1982
ATARAXROERIGNDA 010485—Approved Prior to Jan 1, 1982

Generic (ANDA) products (104)

ProductApplicantApplicationTEApproved
HYDROXYZINE HYDROCHLORIDESAPTALIS PHARMSANDA 220271AAJun 11, 2026
HYDROXYZINE HYDROCHLORIDENOVITIUM PHARMAANDA 219648AADec 16, 2025
HYDROXYZINE HYDROCHLORIDEBIONPHARMAANDA 219289AAApr 28, 2025
HYDROXYZINE HYDROCHLORIDE×3GRAVITI PHARMSANDA 217652ABAug 17, 2023
HYDROXYZINE HYDROCHLORIDEAPOZEAL PHARMSANDA 210634AAFeb 26, 2019
HYDROXYZINE HYDROCHLORIDE×3NUVO PHARMS INCANDA 207121ABMar 29, 2017
HYDROXYZINE HYDROCHLORIDE×3HERITAGEANDA 204279ABAug 20, 2014
HYDROXYZINE HYDROCHLORIDELANNETT CO INCANDA 201674AAAug 21, 2013
HYDROXYZINE HYDROCHLORIDE×3RISINGANDA 091176—Jun 07, 2010
HYDROXYZINE HYDROCHLORIDE×3AMNEAL PHARMANDA 040808—Sep 24, 2008
HYDROXYZINE HYDROCHLORIDE×3CHARTWELL RXANDA 040804ABJun 30, 2008
HYDROXYZINE HYDROCHLORIDE×3SUN PHARM INDS INCANDA 040899—Jun 10, 2008
HYDROXYZINE HYDROCHLORIDE×3HETERO LABS LTD IIIANDA 040805ABMay 29, 2008
HYDROXYZINE HYDROCHLORIDE×3NORTHSTAR HLTHCAREANDA 040840ABMar 31, 2008
HYDROXYZINE HYDROCHLORIDE×3SOMERSET THERAPS LLCANDA 040812—Mar 12, 2008
HYDROXYZINE HYDROCHLORIDE×3KVK TECHANDA 040786ABMar 20, 2007
HYDROXYZINE HYDROCHLORIDE×3PRINSTON INCANDA 040580ABMay 27, 2005
HYDROXYZINE HYDROCHLORIDE×3EPIC PHARMA LLCANDA 040604ABDec 28, 2004
HYDROXYZINE HYDROCHLORIDEABLEANDA 040559—Jul 22, 2004
HYDROXYZINE HYDROCHLORIDEABLEANDA 040562—Jul 22, 2004
HYDROXYZINE HYDROCHLORIDEABLEANDA 040563—Jul 22, 2004
HYDROXYZINE HYDROCHLORIDEPAI HOLDINGS PHARMANDA 040391AAApr 10, 2002
HYDROXYZINE HYDROCHLORIDEPLIVAANDA 081054—Sep 25, 1995
HYDROXYZINE HYDROCHLORIDEHIKMAANDA 040010—Oct 28, 1994
HYDROXYZINE HYDROCHLORIDEWATSON LABSANDA 081149—Mar 18, 1994
HYDROXYZINE HYDROCHLORIDEWATSON LABSANDA 081150—Mar 18, 1994
HYDROXYZINE HYDROCHLORIDEWATSON LABSANDA 081151—Mar 18, 1994
HYDROXYZINE HYDROCHLORIDEHALSEYANDA 089366—May 02, 1988
HYDROXYZINE HYDROCHLORIDEHALSEYANDA 089117—May 02, 1988
HYDROXYZINE HYDROCHLORIDEHALSEYANDA 089396—May 02, 1988
HYDROXYZINE HYDROCHLORIDEALPHARMA US PHARMSANDA 088785—Feb 03, 1988
HYDROXYZINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 089071—Jul 22, 1986
HYDROXYZINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 089072—Jul 22, 1986
HYDROXYZINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 089073—Jul 22, 1986
HYDROXYZINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 089381—May 19, 1986
HYDROXYZINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 089382—May 19, 1986
HYDROXYZINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 089383—May 19, 1986
HYDROXYZINE HYDROCHLORIDEUSL PHARMAANDA 089121—Mar 20, 1986
HYDROXYZINE HYDROCHLORIDEUSL PHARMAANDA 089122—Mar 20, 1986
HYDROXYZINE HYDROCHLORIDEUSL PHARMAANDA 089123—Mar 20, 1986
HYDROXYZINE HYDROCHLORIDEPHARMAFAIRANDA 088862—Feb 14, 1986
HYDROXYZINE HYDROCHLORIDEPHARMAFAIRANDA 089106—Feb 14, 1986
HYDROXYZINE HYDROCHLORIDEPHARMAFAIRANDA 088881—Feb 14, 1986
HYDROXYZINE HYDROCHLORIDEPHARMAFAIRANDA 089107—Feb 14, 1986
HYDROXYZINE HYDROCHLORIDERLDPLIVAANDA 088617ABJan 10, 1986
HYDROXYZINE HYDROCHLORIDERLDPLIVAANDA 088618ABJan 10, 1986
HYDROXYZINE HYDROCHLORIDERLDPLIVAANDA 088619ABJan 10, 1986
HYDROXYZINE HYDROCHLORIDEQUANTUM PHARMICSANDA 088540—Oct 22, 1985
HYDROXYZINE HYDROCHLORIDEQUANTUM PHARMICSANDA 088551—Oct 22, 1985
HYDROXYZINE HYDROCHLORIDEQUANTUM PHARMICSANDA 088529—Oct 22, 1985
HYDROXYZINE HYDROCHLORIDESUPERPHARMANDA 088794—Dec 05, 1984
HYDROXYZINE HYDROCHLORIDESUPERPHARMANDA 088795—Dec 05, 1984
HYDROXYZINE HYDROCHLORIDESUPERPHARMANDA 088796—Dec 05, 1984
HYDROXYZINE HYDROCHLORIDEPUREPAC PHARMANDA 088120—Sep 25, 1984
HYDROXYZINE HYDROCHLORIDEPUREPAC PHARMANDA 088121—Sep 25, 1984
HYDROXYZINE HYDROCHLORIDEPUREPAC PHARMANDA 088122—Sep 25, 1984
HYDROXYZINE HYDROCHLORIDEMUTUAL PHARMANDA 088409—Nov 15, 1983
HYDROXYZINE HYDROCHLORIDEWATSON LABSANDA 088348—Sep 15, 1983
HYDROXYZINE HYDROCHLORIDEWATSON LABSANDA 088349—Sep 15, 1983
HYDROXYZINE HYDROCHLORIDEWATSON LABSANDA 088350—Sep 15, 1983
HYDROXYZINE HYDROCHLORIDEMUTUAL PHARMANDA 087857—Apr 18, 1983
HYDROXYZINE HYDROCHLORIDEMUTUAL PHARMANDA 087860—Apr 18, 1983
HYDROXYZINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 087862—Apr 18, 1983
HYDROXYZINE HYDROCHLORIDEFRESENIUS KABI USAANDA 088184—Mar 31, 1983
HYDROXYZINE HYDROCHLORIDEFRESENIUS KABI USAANDA 088185—Mar 31, 1983
HYDROXYZINE HYDROCHLORIDE×3AUROBINDO PHARMA LTDANDA 087871ABDec 20, 1982
HYDROXYZINE HYDROCHLORIDEKV PHARMANDA 087730—Jul 01, 1982
HYDROXYZINE HYDROCHLORIDEKV PHARMANDA 087819—Jun 23, 1982
HYDROXYZINE HYDROCHLORIDEKV PHARMANDA 087820—Jun 23, 1982
HYDROXYZINE HYDROCHLORIDEKV PHARMANDA 087821—Jun 23, 1982
HYDROXYZINE HYDROCHLORIDEKV PHARMANDA 087822—Jun 23, 1982
HYDROXYZINE HYDROCHLORIDE×2ALTANAANDA 087273—Apr 20, 1982
HYDROXYZINE HYDROCHLORIDERLDCHARTWELL RXANDA 087294AAApr 12, 1982
HYDROXYZINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 087602—Jan 22, 1982
HYDROXYZINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 087603—Jan 22, 1982
HYDROXYZINE HYDROCHLORIDERLDSTRIDES PHARMA INTLANDA 087604—Jan 22, 1982
HYDROXYZINE×2BAXTER HLTHCAREANDA 085551—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDERLD×2AM REGENTANDA 087408—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDEDR REDDYSANDA 085779—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDE×2FRESENIUS KABI USAANDA 087329—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDEHOSPIRAANDA 087416—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDEHOSPIRAANDA 086821—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDEHOSPIRAANDA 087546—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDESMITH AND NEPHEWANDA 087592—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDESOLOPAKANDA 086822—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDESOLOPAKANDA 087591—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDESOLOPAKANDA 087310—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDESOLOPAKANDA 087593—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDESOLOPAKANDA 087595—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDESOLOPAKANDA 087596—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDEWATSON LABSANDA 085778—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDE×2WATSON LABSANDA 087274—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDE×2WYETH AYERSTANDA 086258—Approved Prior to Jan 1, 1982
ORGATRAX×2ORGANON USA INCANDA 087014—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDERISINGANDA 086880—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDEIVAX PHARMSANDA 087216—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDEIVAX PHARMSANDA 087410—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDEIVAX PHARMSANDA 087411—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDESANDOZANDA 087246—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDESANDOZANDA 085247—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDESANDOZANDA 087245—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDEWATSON LABSANDA 086827—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDEWATSON LABSANDA 086829—Approved Prior to Jan 1, 1982
HYDROXYZINE HYDROCHLORIDEWATSON LABSANDA 086836—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.

Hydroxyzine hydrochloride — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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