FDA — authorised 8 January 1953
- Application: NDA008720
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: LEVO-DROMORAN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Levo-Dromoran in United States
FDA authorised Levo-Dromoran on 8 January 1953
Marketing authorisations
FDA
- Status: approved
Levo-Dromoran 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 Levo-Dromoran approved in United States?
Yes. FDA authorised it on 8 January 1953; FDA has authorised it.
Who is the marketing authorisation holder for Levo-Dromoran in United States?
VALEANT PHARM INTL holds the US marketing authorisation.