FDA — authorised 13 May 1949
- Status: approved
🇺🇸 Artane in United States
FDA authorised Artane on 13 May 1949
Marketing authorisations
FDA — authorised 28 May 1985
- Application: ANDA084364
- Marketing authorisation holder: WATSON LABS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 13 August 2001
- Application: ANDA084363
- Marketing authorisation holder: WATSON LABS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 13 August 2002
- Application: ANDA040251
- Marketing authorisation holder: CHARTWELL RX
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 17 November 2010
- Application: ANDA091630
- Marketing authorisation holder: NATCO PHARMA LTD
- Status: approved
FDA — authorised 30 June 2011
- Application: ANDA040177
- Marketing authorisation holder: PHARM ASSOC
- Indication: Labeling
- 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 28 May 1985; FDA authorised it on 13 August 2001.
Who is the marketing authorisation holder for Artane in United States?
Marketing authorisation holder not available in our data.