FDA — authorised 9 April 1953
- Marketing authorisation holder: FOUGERA PHARMS
- Status: approved
🇺🇸 Methylscopolamine in United States
FDA authorised Methylscopolamine on 9 April 1953
Marketing authorisations
FDA — authorised 6 December 2011
- Application: ANDA040642
- Marketing authorisation holder: BRECKENRIDGE PHARM
- Status: approved
FDA — authorised 24 September 2012
- Application: ANDA200602
- Marketing authorisation holder: UNICHEM
- Indication: Not Applicable
- Status: approved
FDA — authorised 1 February 2024
- Application: ANDA216786
- Marketing authorisation holder: NE RX PHARMA
- Status: approved
Methylscopolamine 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 Methylscopolamine approved in United States?
Yes. FDA authorised it on 9 April 1953; FDA authorised it on 6 December 2011; FDA authorised it on 24 September 2012.
Who is the marketing authorisation holder for Methylscopolamine in United States?
FOUGERA PHARMS holds the US marketing authorisation.