Assyro AI

FDA Orange Book · active-ingredient family

Chlorpromazine hydrochloride

Chlorpromazine hydrochloride is approved as 2 brand and 82 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:THORAZINE · NDA 009149

2

Brand (NDA)

82

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, extended release, concentrate, injectable, syrup, tablet

ProductApplicantApplicationTEApproved
THORAZINERLD×9GLAXOSMITHKLINENDA 009149—Approved Prior to Jan 1, 1982
THORAZINE×5GLAXOSMITHKLINENDA 011120—Approved Prior to Jan 1, 1982

Generic (ANDA) products (82)

ProductApplicantApplicationTEApproved
CHLORPROMAZINE HYDROCHLORIDEMSNANDA 216092APJan 26, 2026
CHLORPROMAZINE HYDROCHLORIDE×2RUBICON RESEARCHANDA 216678AAOct 10, 2025
CHLORPROMAZINE HYDROCHLORIDE×5AUROBINDO PHARMA LTDANDA 216788ABApr 25, 2025
CHLORPROMAZINE HYDROCHLORIDETHINQ PHARM-CRO PVTANDA 216724APDec 10, 2024
CHLORPROMAZINE HYDROCHLORIDEASPIROANDA 218272APNov 18, 2024
CHLORPROMAZINE HYDROCHLORIDEGLANDANDA 216911APOct 04, 2024
CHLORPROMAZINE HYDROCHLORIDEDEVA HLDINGANDA 218229APSep 24, 2024
CHLORPROMAZINE HYDROCHLORIDEZYDUS PHARMSANDA 217275APMar 13, 2024
CHLORPROMAZINE HYDROCHLORIDE×5ALEMBICANDA 217350ABJul 18, 2023
CHLORPROMAZINE HYDROCHLORIDE×5LUPINANDA 213327ABJul 13, 2023
CHLORPROMAZINE HYDROCHLORIDE×4MSNANDA 214827ABJan 27, 2022
CHLORPROMAZINE HYDROCHLORIDE×5ZAMEER PHARMSANDA 212630ABNov 29, 2021
CHLORPROMAZINE HYDROCHLORIDE×5TEVA PHARMSANDA 215659ABOct 25, 2021
CHLORPROMAZINE HYDROCHLORIDE×2GENUSANDA 214542AAJun 02, 2021
CHLORPROMAZINE HYDROCHLORIDE×5GLENMARK PHARMS LTDANDA 212144ABMar 23, 2021
CHLORPROMAZINE HYDROCHLORIDE×5LANNETT CO INCANDA 212996ABJan 22, 2021
CHLORPROMAZINE HYDROCHLORIDE×5SUN PHARMANDA 214256—Oct 26, 2020
CHLORPROMAZINE HYDROCHLORIDE×5SOMERSET THERAPS LLCANDA 213590ABAug 31, 2020
CHLORPROMAZINE HYDROCHLORIDEEUGIA PHARMAANDA 211816APJul 07, 2020
CHLORPROMAZINE HYDROCHLORIDE×5ZYDUS LIFESCIENCESANDA 213368ABJan 17, 2020
CHLORPROMAZINE HYDROCHLORIDE×5AMNEAL PHARMS COANDA 209755ABSep 10, 2018
CHLORPROMAZINE HYDROCHLORIDEPHARM ASSOCANDA 040231—Dec 30, 1999
CHLORPROMAZINE HYDROCHLORIDEPHARM ASSOCANDA 040224—Jan 26, 1999
CHLORPROMAZINE HYDROCHLORIDEMARSAM PHARMS LLCANDA 089563—Apr 15, 1988
CHLORPROMAZINE HYDROCHLORIDE INTENSOLHIKMAANDA 088157—Apr 27, 1983
CHLORPROMAZINE HYDROCHLORIDE INTENSOLHIKMAANDA 088158—Apr 27, 1983
CHLORPROMAZINE HYDROCHLORIDEWEST WARDANDA 087783—Sep 16, 1982
CHLORPROMAZINE HYDROCHLORIDEWEST WARDANDA 087865—Sep 16, 1982
CHLORPROMAZINE HYDROCHLORIDEWEST WARDANDA 087880—Sep 16, 1982
CHLORPROMAZINE HYDROCHLORIDEWEST WARDANDA 087878—Sep 15, 1982
CHLORPROMAZINE HYDROCHLORIDEWEST WARDANDA 087884—Sep 15, 1982
CHLORPROMAZINE HYDROCHLORIDEVANGARDANDA 088038—Aug 16, 1982
CHLORPROMAZINE HYDROCHLORIDEWOCKHARDTANDA 087032—Jul 08, 1982
CHLORPROMAZINE HYDROCHLORIDEKV PHARMANDA 085750—Jan 04, 1982
CHLORPROMAZINE HYDROCHLORIDEKV PHARMANDA 085748—Jan 04, 1982
CHLORPROMAZINE HYDROCHLORIDEACTAVIS MID ATLANTICANDA 086863—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEWOCKHARDTANDA 087053—Approved Prior to Jan 1, 1982
SONAZINE×2SAPTALIS PHARMSANDA 080983AAApproved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEABRAXIS PHARMANDA 084911—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEDR REDDYSANDA 080365APApproved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDERLDHIKMAANDA 083329APApproved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEWATSON LABSANDA 085591—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEWYETH AYERSTANDA 080370—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEALPHARMA US PHARMSANDA 086712—Approved Prior to Jan 1, 1982
SONAZINECHARTWELL RXANDA 083040—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEABBOTTANDA 084414—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEABBOTTANDA 084415—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEABBOTTANDA 084411—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEABBOTTANDA 084412—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEABBOTTANDA 084413—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDE×5CHARTWELL RXANDA 080439—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDE×5CYCLEANDA 085331—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDE×3IVAX SUB TEVA PHARMSANDA 083549—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083574—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083575—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEKV PHARMANDA 085751—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEKV PHARMANDA 085484—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEKV PHARMANDA 085752—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDELEDERLEANDA 084803—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDELEDERLEANDA 084801—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDELEDERLEANDA 084800—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDELEDERLEANDA 084789—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDELEDERLEANDA 084802—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDE×5PUREPAC PHARMANDA 080403—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDE×3PVT FORMANDA 080340—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDERLDUPSHER SMITH LABSANDA 083386ABApproved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDERLDUPSHER SMITH LABSANDA 084112ABApproved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDERLDUPSHER SMITH LABSANDA 084113ABApproved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDERLDUPSHER SMITH LABSANDA 084114ABApproved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDERLDUPSHER SMITH LABSANDA 084115ABApproved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEVANGARDANDA 087645—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEVANGARDANDA 087646—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEWATSON LABSANDA 085959—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEWATSON LABSANDA 085956—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEWATSON LABSANDA 085960—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEWATSON LABSANDA 085957—Approved Prior to Jan 1, 1982
CHLORPROMAZINE HYDROCHLORIDEWATSON LABSANDA 085958—Approved Prior to Jan 1, 1982
PROMAPARPARKE DAVISANDA 086886—Approved Prior to Jan 1, 1982
PROMAPARPARKE DAVISANDA 084423—Approved Prior to Jan 1, 1982
PROMAPARPARKE DAVISANDA 086887—Approved Prior to Jan 1, 1982
PROMAPARPARKE DAVISANDA 086888—Approved Prior to Jan 1, 1982
PROMAPARPARKE DAVISANDA 086885—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.

Chlorpromazine hydrochloride — frequently asked questions

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

Agent CTA Background

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