FDA — authorised 28 February 1977
- Application: NDA017856
- Marketing authorisation holder: TARO
- Local brand name: TOPICORT
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Topicort in United States
FDA authorised Topicort on 28 February 1977
Marketing authorisations
FDA — authorised 28 February 1977
- Marketing authorisation holder: TARO PHARMS NORTH
- Status: approved
FDA — authorised 29 March 1982
- Application: NDA018586
- Marketing authorisation holder: TARO
- Local brand name: TOPICORT
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 3 October 1983
- Application: NDA018763
- Marketing authorisation holder: TARO
- Local brand name: TOPICORT
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 17 January 1985
- Application: NDA018594
- Marketing authorisation holder: TARO
- Local brand name: TOPICORT
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 7 June 1996
- Application: ANDA074286
- Marketing authorisation holder: TARO
- Local brand name: TOPICORT
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 14 July 1998
- Application: ANDA074904
- Marketing authorisation holder: TARO
- Local brand name: TOPICORT
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 19 December 2003
- Application: ANDA073193
- Marketing authorisation holder: TARO
- Indication: Labeling
- Status: approved
FDA — authorised 11 April 2013
- Application: NDA204141
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: TOPICORT
- Indication: SPRAY — TOPICAL
- Status: approved
FDA — authorised 20 April 2015
- Application: ANDA077770
- Marketing authorisation holder: PADAGIS ISRAEL
- Status: approved
FDA — authorised 12 December 2016
- Application: ANDA208044
- Marketing authorisation holder: LUPIN
- Status: approved
FDA — authorised 16 March 2026
- Application: ANDA203787
- Marketing authorisation holder: SCIEGEN PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved the manufacturing (CMC) indication for Topicort, a pharmaceutical product, on 16 March 2026. The marketing authorisation holder is SCIEGEN PHARMS. This approval was granted under the standard expedited pathway.
Topicort 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 Topicort approved in United States?
Yes. FDA authorised it on 28 February 1977; FDA authorised it on 28 February 1977; FDA authorised it on 29 March 1982.
Who is the marketing authorisation holder for Topicort in United States?
TARO holds the US marketing authorisation.