FDA — authorised 20 June 1972
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Status: approved
🇺🇸 Prolixin Decanoate in United States
FDA authorised Prolixin Decanoate on 20 June 1972
Marketing authorisations
FDA — authorised 20 June 1972
- Application: NDA016727
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: PROLIXIN DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 July 1987
- Application: ANDA071413
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FLUPHENAZINE DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 August 1996
- Application: ANDA074531
- Marketing authorisation holder: HIKMA
- Local brand name: FLUPHENAZINE DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 1998
- Application: ANDA074966
- Marketing authorisation holder: HOSPIRA
- Local brand name: FLUPHENAZINE DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 August 2001
- Application: ANDA075918
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: FLUPHENAZINE DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 July 2014
- Application: ANDA203732
- Marketing authorisation holder: PH HEALTH
- Local brand name: FLUPHENAZINE DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 November 2023
- Application: ANDA215365
- Marketing authorisation holder: MSN
- Local brand name: FLUPHENAZINE DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Prolixin Decanoate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Prolixin Decanoate approved in United States?
Yes. FDA authorised it on 20 June 1972; FDA authorised it on 20 June 1972; FDA authorised it on 14 July 1987.
Who is the marketing authorisation holder for Prolixin Decanoate in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.