FDA — authorised 11 June 2003
- Application: NDA021485
- Marketing authorisation holder: ORION PHARMA
- Local brand name: STALEVO 100
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 5HTP in United States
FDA authorised 5HTP on 11 June 2003
Marketing authorisations
FDA — authorised 20 November 2012
- Application: ANDA090786
- Marketing authorisation holder: WOCKHARDT LTD
- Local brand name: CARBIDOPA, LEVODOPA AND ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 November 2012
- Application: ANDA090833
- Marketing authorisation holder: WOCKHARDT LTD
- Local brand name: CARBIDOPA, LEVODOPA AND ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 March 2014
- Application: ANDA203261
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CARBIDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 October 2017
- Application: ANDA204763
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: CARBIDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 October 2019
- Application: ANDA211055
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CARBIDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 November 2021
- Application: NDA214869
- Marketing authorisation holder: AVION PHARMS
- Local brand name: DHIVY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 January 2022
- Application: ANDA213212
- Marketing authorisation holder: RISING
- Local brand name: CARBIDOPA, LEVODOPA AND ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 2025
- Application: ANDA214495
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: CARBIDOPA, LEVODOPA AND ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
5HTP 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 5HTP approved in United States?
Yes. FDA authorised it on 11 June 2003; FDA authorised it on 20 November 2012; FDA authorised it on 20 November 2012.
Who is the marketing authorisation holder for 5HTP in United States?
ORION PHARMA holds the US marketing authorisation.