FDA — authorised 12 April 2007
- Application: NDA022055
- Marketing authorisation holder: ALMIRALL
- Local brand name: ALTABAX
- Indication: OINTMENT — TOPICAL
- Status: approved
🇺🇸 retapamulin 1% ointment in United States
FDA authorised retapamulin 1% ointment on 12 April 2007
Marketing authorisations
FDA
- Status: approved
retapamulin 1% ointment in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is retapamulin 1% ointment approved in United States?
Yes. FDA authorised it on 12 April 2007; FDA has authorised it.
Who is the marketing authorisation holder for retapamulin 1% ointment in United States?
ALMIRALL holds the US marketing authorisation.