FDA — authorised 13 December 2001
- Marketing authorisation holder: VALEANT BERMUDA
- Status: approved
🇺🇸 Elidel in United States
FDA authorised Elidel on 13 December 2001
Marketing authorisations
FDA — authorised 27 December 2018
- Application: ANDA209345
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: PIMECROLIMUS
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 29 August 2019
- Application: ANDA211769
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: PIMECROLIMUS
- Indication: CREAM — TOPICAL
- Status: approved
Elidel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Elidel approved in United States?
Yes. FDA authorised it on 13 December 2001; FDA authorised it on 27 December 2018; FDA authorised it on 29 August 2019.
Who is the marketing authorisation holder for Elidel in United States?
VALEANT BERMUDA holds the US marketing authorisation.