FDA — authorised 14 December 1982
- Application: NDA018702
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: ACLOVATE
- Indication: OINTMENT — TOPICAL
- Status: approved
🇺🇸 Aclovate in United States
FDA authorised Aclovate on 14 December 1982
Marketing authorisations
FDA — authorised 29 July 2004
- Application: ANDA076730
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: ALCLOMETASONE DIPROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 12 July 2005
- Application: ANDA076973
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: ALCLOMETASONE DIPROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 18 July 2005
- Application: ANDA076884
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: ALCLOMETASONE DIPROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 15 September 2005
- Application: ANDA076587
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: ALCLOMETASONE DIPROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 23 June 2009
- Application: ANDA079061
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ALCLOMETASONE DIPROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 30 July 2009
- Application: ANDA079227
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ALCLOMETASONE DIPROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
Aclovate 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 Aclovate approved in United States?
Yes. FDA authorised it on 14 December 1982; FDA authorised it on 29 July 2004; FDA authorised it on 12 July 2005.
Who is the marketing authorisation holder for Aclovate in United States?
FOUGERA PHARMS holds the US marketing authorisation.