FDA Orange Book · active-ingredient family
Chlorpromazine hydrochloride
Chlorpromazine hydrochloride: 2 brands, 82 generics; first approved Jan 04, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 82 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
82
Listed patents
0
Presentations
162
Brand (NDA) products
Originator applications
- THORAZINERLDGLAXOSMITHKLINENDA 009149—9 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 25MG/ML INJECTABLE INJECTION Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — 10MG/5ML SYRUP ORAL Discontinued — 30MG/ML CONCENTRATE ORAL Discontinued — 100MG/ML CONCENTRATE ORAL Discontinued — - GLAXOSMITHKLINENDA 011120—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 75MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 150MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 200MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 300MG CAPSULE, EXTENDED RELEASE ORAL Discontinued —
Generic (ANDA) products (82)
Abbreviated applications
- CHLORPROMAZINE HYDROCHLORIDEMSNANDA 2160922026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AP - CHLORPROMAZINE HYDROCHLORIDERUBICON RESEARCHANDA 21667820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/ML CONCENTRATE ORAL Rx AA 100MG/ML CONCENTRATE ORAL Rx AA - CHLORPROMAZINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 21678820255 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDETHINQ PHARM-CRO PVTANDA 2167242024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AP - CHLORPROMAZINE HYDROCHLORIDEASPIROANDA 2182722024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AP - CHLORPROMAZINE HYDROCHLORIDEGLANDANDA 2169112024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AP - CHLORPROMAZINE HYDROCHLORIDEDEVA HLDINGANDA 2182292024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AP - CHLORPROMAZINE HYDROCHLORIDEZYDUS PHARMSANDA 2172752024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AP - CHLORPROMAZINE HYDROCHLORIDEALEMBICANDA 21735020235 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDELUPINANDA 21332720235 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDEMSNANDA 21482720224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDEZAMEER PHARMSANDA 21263020215 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDETEVA PHARMSANDA 21565920215 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDERSGENUSANDA 21454220212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/ML CONCENTRATE ORAL Rx AA 100MG/ML CONCENTRATE ORAL Rx AA - CHLORPROMAZINE HYDROCHLORIDEGLENMARK PHARMS LTDANDA 21214420215 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDELANNETT CO INCANDA 21299620215 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDESUN PHARMANDA 21425620205 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 — 200MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 21359020205 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDEEUGIA PHARMAANDA 2118162020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AP - CHLORPROMAZINE HYDROCHLORIDEZYDUS LIFESCIENCESANDA 21336820205 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDEAMNEAL PHARMS COANDA 20975520185 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDEPHARM ASSOCANDA 0402311999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/ML CONCENTRATE ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEPHARM ASSOCANDA 0402241999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML CONCENTRATE ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEMARSAM PHARMS LLCANDA 0895631988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - HIKMAANDA 0881571983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/ML CONCENTRATE ORAL Discontinued — - HIKMAANDA 0881581983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML CONCENTRATE ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWEST WARDANDA 0877831982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWEST WARDANDA 0878651982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWEST WARDANDA 0878801982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWEST WARDANDA 0878781982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWEST WARDANDA 0878841982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEVANGARDANDA 0880381982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWOCKHARDTANDA 0870321982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/ML CONCENTRATE ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEKV PHARMANDA 0857501982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEKV PHARMANDA 0857481982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEACTAVIS MID ATLANTICANDA 086863—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML CONCENTRATE ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWOCKHARDTANDA 087053—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML CONCENTRATE ORAL Discontinued — - SAPTALIS PHARMSANDA 080983—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/ML CONCENTRATE ORAL Rx AA 100MG/ML CONCENTRATE ORAL Rx AA - CHLORPROMAZINE HYDROCHLORIDEABRAXIS PHARMANDA 084911—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - CHLORPROMAZINE HYDROCHLORIDEDR REDDYSANDA 080365—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AP - CHLORPROMAZINE HYDROCHLORIDERLDRSHIKMAANDA 083329—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AP - CHLORPROMAZINE HYDROCHLORIDEWATSON LABSANDA 085591—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWYETH AYERSTANDA 080370—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - CHLORPROMAZINE HYDROCHLORIDEALPHARMA US PHARMSANDA 086712—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Discontinued — - CHARTWELL RXANDA 083040—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEABBOTTANDA 084414—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEABBOTTANDA 084415—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEABBOTTANDA 084411—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEABBOTTANDA 084412—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEABBOTTANDA 084413—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDECHARTWELL RXANDA 080439—5 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 — 200MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDECYCLEANDA 085331—5 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 — 200MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083549—3 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 — - CHLORPROMAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083574—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083575—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEKV PHARMANDA 085751—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEKV PHARMANDA 085484—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEKV PHARMANDA 085752—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDELEDERLEANDA 084803—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDELEDERLEANDA 084801—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDELEDERLEANDA 084800—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDELEDERLEANDA 084789—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDELEDERLEANDA 084802—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEPUREPAC PHARMANDA 080403—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEPVT FORMANDA 080340—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDERLDUPSHER SMITH LABSANDA 083386—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDERLDRSUPSHER SMITH LABSANDA 084112—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDERLDUPSHER SMITH LABSANDA 084113—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDERLDRSUPSHER SMITH LABSANDA 084114—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDERLDUPSHER SMITH LABSANDA 084115—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - CHLORPROMAZINE HYDROCHLORIDEVANGARDANDA 087645—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEVANGARDANDA 087646—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWATSON LABSANDA 085959—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWATSON LABSANDA 085956—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWATSON LABSANDA 085960—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWATSON LABSANDA 085957—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - CHLORPROMAZINE HYDROCHLORIDEWATSON LABSANDA 085958—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - PARKE DAVISANDA 086886—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PARKE DAVISANDA 084423—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - PARKE DAVISANDA 086887—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - PARKE DAVISANDA 086888—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - PARKE DAVISANDA 086885—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG 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
7 mo ago
Approvals span 1982–2026 across 84 FDA applications.
Brand (NDA) 22%
Generic (ANDA) 8298%
Chlorpromazine 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.
