FDA — authorised 27 February 1997
- Application: NDA020723
- Marketing authorisation holder: BAUSCH
- Local brand name: ALDARA
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Aldara in United States
FDA authorised Aldara on 27 February 1997
Marketing authorisations
FDA — authorised 27 February 1997
- Marketing authorisation holder: MEDICIS
- Status: approved
FDA — authorised 25 February 2010
- Application: ANDA078548
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: IMIQUIMOD
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 7 September 2010
- Application: ANDA078837
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: IMIQUIMOD
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 15 April 2011
- Application: ANDA200173
- Marketing authorisation holder: TARO
- Local brand name: IMIQUIMOD
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 18 April 2011
- Application: ANDA200481
- Marketing authorisation holder: COSETTE
- Local brand name: IMIQUIMOD
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 6 March 2012
- Application: ANDA201994
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: IMIQUIMOD
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 6 April 2012
- Application: ANDA091308
- Marketing authorisation holder: APOTEX INC
- Local brand name: IMIQUIMOD
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 24 June 2014
- Application: ANDA202002
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: IMIQUIMOD
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 January 2021
- Application: ANDA205971
- Marketing authorisation holder: TARO
- Local brand name: IMIQUIMOD
- Indication: CREAM — TOPICAL
- Status: approved
Aldara 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 Aldara approved in United States?
Yes. FDA authorised it on 27 February 1997; FDA authorised it on 27 February 1997; FDA authorised it on 25 February 2010.
Who is the marketing authorisation holder for Aldara in United States?
BAUSCH holds the US marketing authorisation.