FDA — authorised 16 March 1972
- Application: ANDA084803
- Marketing authorisation holder: LEDERLE
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 CHLORPROMAZINE HYDROCHLORIDE in United States
FDA authorised CHLORPROMAZINE HYDROCHLORIDE on 16 March 1972
Marketing authorisations
FDA — authorised 3 January 1973
- Application: ANDA080439
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 May 1974
- Application: ANDA083549
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 May 1974
- Application: ANDA083574
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 May 1974
- Application: ANDA083575
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 1974
- Application: ANDA084113
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 1974
- Application: ANDA084115
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 1974
- Application: ANDA084114
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 1974
- Application: ANDA083386
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 1974
- Application: ANDA084112
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 1974
- Application: ANDA083329
- Marketing authorisation holder: HIKMA
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 March 1976
- Application: ANDA080983
- Marketing authorisation holder: SAPTALIS PHARMS
- Local brand name: SONAZINE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 4 March 1976
- Application: ANDA083040
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: SONAZINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 1 July 1977
- Application: ANDA085591
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 December 1977
- Application: ANDA084911
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 February 1978
- Application: ANDA085748
- Marketing authorisation holder: KV PHARM
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 1978
- Application: ANDA085750
- Marketing authorisation holder: KV PHARM
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 1978
- Application: ANDA085484
- Marketing authorisation holder: KV PHARM
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 1978
- Application: ANDA085751
- Marketing authorisation holder: KV PHARM
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 1978
- Application: ANDA085752
- Marketing authorisation holder: KV PHARM
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 November 1979
- Application: ANDA085956
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 November 1979
- Application: ANDA085960
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 August 1980
- Application: ANDA086888
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: PROMAPAR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 August 1980
- Application: ANDA086886
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: PROMAPAR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 August 1980
- Application: ANDA086885
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: PROMAPAR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 November 1980
- Application: ANDA086863
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 10 November 1980
- Application: ANDA086712
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 17 December 1980
- Application: ANDA085957
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 1980
- Application: ANDA085959
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 1980
- Application: ANDA085958
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 February 1981
- Application: ANDA087053
- Marketing authorisation holder: WOCKHARDT
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 14 December 1981
- Application: ANDA087645
- Marketing authorisation holder: VANGARD
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 December 1981
- Application: ANDA087646
- Marketing authorisation holder: VANGARD
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 June 1982
- Application: ANDA084800
- Marketing authorisation holder: LEDERLE
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 June 1982
- Application: ANDA084802
- Marketing authorisation holder: LEDERLE
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 June 1982
- Application: ANDA084789
- Marketing authorisation holder: LEDERLE
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 June 1982
- Application: ANDA084801
- Marketing authorisation holder: LEDERLE
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 1982
- Application: ANDA080403
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 July 1982
- Application: ANDA087032
- Marketing authorisation holder: WOCKHARDT
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 16 August 1982
- Application: ANDA088038
- Marketing authorisation holder: VANGARD
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 1982
- Application: ANDA087865
- Marketing authorisation holder: WEST WARD
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 1988
- Application: ANDA089563
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 January 1999
- Application: ANDA040224
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 30 December 1999
- Application: ANDA040231
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 10 September 2018
- Application: ANDA209755
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 January 2020
- Application: ANDA213368
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2020
- Application: ANDA211816
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 2020
- Application: ANDA213590
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2021
- Application: ANDA212996
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 2021
- Application: ANDA212144
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 June 2021
- Application: ANDA214542
- Marketing authorisation holder: GENUS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 25 October 2021
- Application: ANDA215659
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 2021
- Application: ANDA212630
- Marketing authorisation holder: ZAMEER PHARMS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2022
- Application: ANDA214827
- Marketing authorisation holder: MSN
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 2023
- Application: ANDA213327
- Marketing authorisation holder: LUPIN
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 July 2023
- Application: ANDA217350
- Marketing authorisation holder: ALEMBIC
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 March 2024
- Application: ANDA217275
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 September 2024
- Application: ANDA218229
- Marketing authorisation holder: DEVA HLDING
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 October 2024
- Application: ANDA216911
- Marketing authorisation holder: GLAND
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 November 2024
- Application: ANDA218272
- Marketing authorisation holder: ASPIRO
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 December 2024
- Application: ANDA216724
- Marketing authorisation holder: THINQ PHARM-CRO PVT
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 April 2025
- Application: ANDA216788
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 10 October 2025
- Application: ANDA216678
- Marketing authorisation holder: RUBICON
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 26 January 2026
- Application: ANDA216092
- Marketing authorisation holder: MSN
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved MSN's application (ANDA216092) for CHLORPROMAZINE HYDROCHLORIDE injection on 26 January 2026. This approval allows MSN to market CHLORPROMAZINE HYDROCHLORIDE injection in the United States. The indication approved is for injectable use.
FDA
- Application: ANDA084414
- Marketing authorisation holder: ABBOTT
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084413
- Marketing authorisation holder: ABBOTT
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086887
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: PROMAPAR
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084412
- Marketing authorisation holder: ABBOTT
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087884
- Marketing authorisation holder: WEST WARD
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087880
- Marketing authorisation holder: WEST WARD
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087878
- Marketing authorisation holder: WEST WARD
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084411
- Marketing authorisation holder: ABBOTT
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA087783
- Marketing authorisation holder: WEST WARD
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084415
- Marketing authorisation holder: ABBOTT
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085331
- Marketing authorisation holder: CYCLE
- Local brand name: CHLORPROMAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is CHLORPROMAZINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 16 March 1972; FDA authorised it on 3 January 1973; FDA authorised it on 6 May 1974.
Who is the marketing authorisation holder for CHLORPROMAZINE HYDROCHLORIDE in United States?
LEDERLE holds the US marketing authorisation.