FDA — authorised 9 September 1959
- Status: approved
🇺🇸 Prolixin in United States
FDA authorised Prolixin on 9 September 1959
Marketing authorisations
FDA — authorised 23 December 1959
- Application: NDA012145
- Marketing authorisation holder: APOTHECON
- Local brand name: PROLIXIN
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 24 August 1960
- Application: NDA011751
- Marketing authorisation holder: APOTHECON
- Local brand name: PROLIXIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 November 1985
- Application: ANDA070533
- Marketing authorisation holder: APOTHECON
- Local brand name: PROLIXIN
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 3 December 2010
- Application: ANDA040146
- Marketing authorisation holder: PHARM ASSOC
- Indication: Labeling
- Status: approved
FDA — authorised 2 November 2023
- Application: ANDA215365
- Marketing authorisation holder: MSN
- Status: approved
FDA — authorised 22 January 2025
- Application: ANDA215848
- Marketing authorisation holder: TWI PHARMS
- Indication: Labeling
- Status: approved
The FDA approved Prolixin for its labelled indication on 22 January 2025. This approval was granted to TWI PHARMS under the standard expedited pathway. The application number for this approval is ANDA215848.
FDA — authorised 22 January 2025
- Application: ANDA214534
- Marketing authorisation holder: DR REDDYS
- Indication: Labeling
- Status: approved
The FDA approved Prolixin for its labelled indication on 22 January 2025. DR REDDYS, the marketing authorisation holder, submitted application number ANDA214534. The approval was granted under the standard expedited pathway.
FDA — authorised 24 January 2025
- Application: ANDA214552
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Indication: Labeling
- Status: approved
The FDA approved Prolixin, a drug product, on 24 January 2025. The marketing authorisation holder is ZYDUS LIFESCIENCES. The approval was granted through the standard expedited pathway. Prolixin is indicated for the treatment of schizophrenia, as stated in the labelling.
FDA
- Application: ANDA070762
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: FLUPHENAZINE
- Indication: Injectable — Injection
- Status: approved
Prolixin 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 approved in United States?
Yes. FDA authorised it on 9 September 1959; FDA authorised it on 23 December 1959; FDA authorised it on 24 August 1960.
Who is the marketing authorisation holder for Prolixin in United States?
Marketing authorisation holder not available in our data.