FDA — authorised 28 May 1964
- Status: approved
🇺🇸 Orabolin in United States
FDA authorised Orabolin on 28 May 1964
Marketing authorisations
FDA — authorised 28 May 1964
- Application: NDA014005
- Marketing authorisation holder: ORGANON USA INC
- Local brand name: MAXIBOLIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 1965
- Application: NDA014006
- Marketing authorisation holder: ORGANON USA INC
- Local brand name: MAXIBOLIN
- Indication: ELIXIR — ORAL
- Status: approved
Orabolin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Nephrology approved in United States
Frequently asked questions
Is Orabolin approved in United States?
Yes. FDA authorised it on 28 May 1964; FDA authorised it on 28 May 1964; FDA authorised it on 7 January 1965.
Who is the marketing authorisation holder for Orabolin in United States?
Marketing authorisation holder not available in our data.