FDA
- Status: approved
🇺🇸 Active Comparator in United States
Active Comparator (Active Comparator) regulatory status in United States.
Marketing authorisation
Active Comparator in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Psychiatry approved in United States
Frequently asked questions
Is Active Comparator approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Active Comparator in United States?
PT Bio Farma is the originator. The local marketing authorisation holder may differ — check the official source linked above.