FDA — authorised 9 September 1959
- Application: NDA012034
- Marketing authorisation holder: SCHERING
- Local brand name: PERMITIL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 FLUPHENAZINE HYDROCHLORIDE in United States
FDA authorised FLUPHENAZINE HYDROCHLORIDE on 9 September 1959
Marketing authorisations
FDA — authorised 24 June 1960
- Application: NDA012419
- Marketing authorisation holder: SCHERING
- Local brand name: PERMITIL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 October 1987
- Application: ANDA089586
- Marketing authorisation holder: SANDOZ
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 1987
- Application: ANDA089585
- Marketing authorisation holder: SANDOZ
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 August 1988
- Application: ANDA089804
- Marketing authorisation holder: PRASCO
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 1988
- Application: ANDA089741
- Marketing authorisation holder: LANNETT
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 1988
- Application: ANDA089743
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 1988
- Application: ANDA089742
- Marketing authorisation holder: LANNETT
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 1988
- Application: ANDA089740
- Marketing authorisation holder: LANNETT
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 August 1991
- Application: ANDA073058
- Marketing authorisation holder: ANI PHARMS
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 29 April 1993
- Application: ANDA081310
- Marketing authorisation holder: ANI PHARMS
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 21 August 1996
- Application: ANDA040146
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 16 September 1996
- Application: ANDA074725
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 9 July 2020
- Application: ANDA213647
- Marketing authorisation holder: AMNEAL
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 2021
- Application: ANDA214534
- Marketing authorisation holder: DR REDDYS
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 May 2021
- Application: ANDA214552
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 October 2021
- Application: ANDA215141
- Marketing authorisation holder: ZAMEER PHARMS
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 April 2022
- Application: ANDA215848
- Marketing authorisation holder: TWI PHARMS
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 April 2022
- Application: ANDA215674
- Marketing authorisation holder: TARO
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 July 2022
- Application: ANDA216649
- Marketing authorisation holder: APOTEX
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 October 2022
- Application: ANDA213784
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 November 2022
- Application: ANDA216891
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 2023
- Application: ANDA217410
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 2023
- Application: ANDA218055
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 September 2023
- Application: ANDA217189
- Marketing authorisation holder: MSN
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2024
- Application: ANDA217094
- Marketing authorisation holder: TORRENT
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 June 2024
- Application: ANDA218283
- Marketing authorisation holder: RISING
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 July 2024
- Application: ANDA218173
- Marketing authorisation holder: ALEMBIC
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 November 2025
- Application: ANDA218769
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088544
- Marketing authorisation holder: WATSON LABS
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA088550
- Marketing authorisation holder: WATSON LABS
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088527
- Marketing authorisation holder: WATSON LABS
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088555
- Marketing authorisation holder: WATSON LABS
- Local brand name: FLUPHENAZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FLUPHENAZINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is FLUPHENAZINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 9 September 1959; FDA authorised it on 24 June 1960; FDA authorised it on 16 October 1987.
Who is the marketing authorisation holder for FLUPHENAZINE HYDROCHLORIDE in United States?
SCHERING holds the US marketing authorisation.