FDA — authorised 29 October 1993
- Application: NDA020279
- Marketing authorisation holder: VALEANT BERMUDA
- Local brand name: DERMATOP E EMOLLIENT
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Dermatop in United States
FDA authorised Dermatop on 29 October 1993
Marketing authorisations
FDA — authorised 9 March 2007
- Application: ANDA077236
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: PREDNICARBATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Status: approved
Dermatop in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Dermatop approved in United States?
Yes. FDA authorised it on 29 October 1993; FDA authorised it on 9 March 2007; FDA has authorised it.
Who is the marketing authorisation holder for Dermatop in United States?
VALEANT BERMUDA holds the US marketing authorisation.