FDA — authorised 24 July 1967
- Marketing authorisation holder: PFIZER
- Status: approved
🇺🇸 Navane in United States
FDA authorised Navane on 24 July 1967
Marketing authorisations
FDA — authorised 24 July 1967
- Application: NDA016584
- Marketing authorisation holder: PFIZER
- Local brand name: NAVANE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 April 1970
- Application: NDA016758
- Marketing authorisation holder: PFIZER
- Local brand name: NAVANE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 19 August 1971
- Application: NDA016904
- Marketing authorisation holder: PFIZER
- Local brand name: NAVANE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 June 1987
- Application: ANDA071093
- Marketing authorisation holder: RISING
- Local brand name: THIOTHIXENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 June 1987
- Application: ANDA071529
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: THIOTHIXENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 June 1987
- Application: ANDA071530
- Marketing authorisation holder: SANDOZ
- Local brand name: THIOTHIXENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 February 2022
- Application: ANDA215456
- Marketing authorisation holder: AMNEAL
- Local brand name: THIOTHIXENE
- Indication: CAPSULE — ORAL
- Status: approved
The FDA approved Navane, manufactured by AMNEAL, under the application number ANDA215456 on 22 January 2025. This approval was granted through the standard expedited pathway. The approved indication for Navane is listed in its labelling, but the specific indication is not reported in the available data.
FDA — authorised 22 January 2025
- Application: ANDA211642
- Marketing authorisation holder: NOVITIUM PHARMA
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to Navane on 22 January 2025. Navane is a pharmaceutical product, but the specific local brand name is not reported. The marketing authorisation holder is Novitium Pharma. The approval was granted through the standard expedited pathway.
FDA
- Application: ANDA071885
- Marketing authorisation holder: AM THERAP
- Local brand name: THIOTHIXENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071886
- Marketing authorisation holder: AM THERAP
- Local brand name: THIOTHIXENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071887
- Marketing authorisation holder: AM THERAP
- Local brand name: THIOTHIXENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071884
- Marketing authorisation holder: AM THERAP
- Local brand name: THIOTHIXENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072200
- Marketing authorisation holder: AM THERAP
- Local brand name: THIOTHIXENE
- Indication: CAPSULE — ORAL
- Status: approved
Navane 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 Navane approved in United States?
Yes. FDA authorised it on 24 July 1967; FDA authorised it on 24 July 1967; FDA authorised it on 6 April 1970.
Who is the marketing authorisation holder for Navane in United States?
PFIZER holds the US marketing authorisation.