FDA — authorised 31 March 1982
- Marketing authorisation holder: PRECISION DERMAT
- Status: approved
🇺🇸 Locoid in United States
FDA authorised Locoid on 31 March 1982
Marketing authorisations
FDA — authorised 14 January 2004
- Application: ANDA076364
- Marketing authorisation holder: TARO PHARM INDS
- Local brand name: HYDROCORTISONE BUTYRATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 27 December 2004
- Application: ANDA076842
- Marketing authorisation holder: TARO
- Local brand name: HYDROCORTISONE BUTYRATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 3 August 2005
- Application: ANDA076654
- Marketing authorisation holder: TARO PHARM INDS
- Local brand name: HYDROCORTISONE BUTYRATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 27 September 2013
- Application: ANDA202145
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: HYDROCORTISONE BUTYRATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 19 November 2013
- Application: NDA022076
- Marketing authorisation holder: BAUSCH
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 21 November 2017
- Application: ANDA209556
- Marketing authorisation holder: THE J MOLNER
- Local brand name: HYDROCORTISONE BUTYRATE
- Indication: LOTION — TOPICAL
- Status: approved
The FDA approved Locoid, a pharmaceutical product, on 2024-04-30. The marketing authorisation holder is THE J MOLNER. The product was approved through the standard expedited pathway. The indication approved is for labeling.
FDA — authorised 8 December 2017
- Application: ANDA205134
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: HYDROCORTISONE BUTYRATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 17 August 2018
- Application: ANDA210209
- Marketing authorisation holder: LUPIN
- Local brand name: HYDROCORTISONE BUTYRATE
- Indication: LOTION — TOPICAL
- Status: approved
Locoid 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 Locoid approved in United States?
Yes. FDA authorised it on 31 March 1982; FDA authorised it on 14 January 2004; FDA authorised it on 27 December 2004.
Who is the marketing authorisation holder for Locoid in United States?
PRECISION DERMAT holds the US marketing authorisation.