FDA — authorised 13 May 1949
- Application: NDA006773
- Marketing authorisation holder: LEDERLE
- Local brand name: ARTANE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Artane in United States
FDA authorised Artane on 13 May 1949
Marketing authorisations
FDA — authorised 18 April 1962
- Application: NDA012947
- Marketing authorisation holder: LEDERLE
- Local brand name: ARTANE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 November 1974
- Application: ANDA084363
- Marketing authorisation holder: WATSON LABS
- Local brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 December 1974
- Application: ANDA084364
- Marketing authorisation holder: WATSON LABS
- Local brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 July 1982
- Application: ANDA088035
- Marketing authorisation holder: VANGARD
- Local brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 December 1998
- Application: ANDA040254
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 1999
- Application: ANDA040251
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 16 February 2000
- Application: ANDA040337
- Marketing authorisation holder: HIKMA
- Local brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 November 2010
- Application: ANDA091630
- Marketing authorisation holder: NATCO PHARMA LTD
- Local brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 2011
- Application: ANDA040177
- Marketing authorisation holder: PHARM ASSOC
- Indication: Labeling
- Status: approved
FDA
- Application: ANDA085105
- Marketing authorisation holder: WATSON LABS
- Local brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085117
- Marketing authorisation holder: WATSON LABS
- Local brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085622
- Marketing authorisation holder: NYLOS
- Local brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
Artane 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 Artane approved in United States?
Yes. FDA authorised it on 13 May 1949; FDA authorised it on 18 April 1962; FDA authorised it on 26 November 1974.
Who is the marketing authorisation holder for Artane in United States?
LEDERLE holds the US marketing authorisation.