FDA — authorised 16 February 1994
- Application: ANDA074087
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Topical steroid in United States
FDA authorised Topical steroid on 16 February 1994 · 60 US adverse-event reports
Marketing authorisations
FDA — authorised 16 February 1994
- Application: ANDA074089
- Marketing authorisation holder: COSETTE
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 17 June 1994
- Application: NDA020340
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: TEMOVATE E
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 31 March 1995
- Application: ANDA074221
- Marketing authorisation holder: HIKMA
- Local brand name: EMBELINE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 6 December 1995
- Application: ANDA074222
- Marketing authorisation holder: HIKMA
- Local brand name: EMBELINE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 15 December 1995
- Application: ANDA074331
- Marketing authorisation holder: COSETTE
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 23 February 1996
- Application: ANDA074407
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 8 July 1996
- Application: ANDA074249
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 12 July 1996
- Application: ANDA074248
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 30 September 1996
- Application: ANDA074392
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 16 May 1997
- Application: ANDA074220
- Marketing authorisation holder: HIKMA
- Local brand name: CORMAX
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 31 October 1997
- Application: ANDA075027
- Marketing authorisation holder: PADAGIS US
- Local brand name: CLOBETASOL PROPIONATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 12 August 1998
- Application: ANDA075057
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 13 November 1998
- Application: ANDA075205
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 16 November 1998
- Application: ANDA075224
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 24 December 1998
- Application: ANDA075325
- Marketing authorisation holder: HIKMA
- Local brand name: EMBELINE E
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 8 February 1999
- Application: ANDA075391
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 28 May 1999
- Application: ANDA075279
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOBETASOL PROPIONATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 15 February 2000
- Application: ANDA075368
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CLOBETASOL PROPIONATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 17 May 2000
- Application: ANDA075633
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOBETASOL PROPIONATE (EMOLLIENT)
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 May 2000
- Application: NDA021142
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: OLUX
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 29 December 2000
- Application: ANDA075363
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 9 February 2001
- Application: ANDA075338
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 22 August 2001
- Application: ANDA075733
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CLOBETASOL PROPIONATE (EMOLLIENT)
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 12 April 2002
- Application: ANDA076141
- Marketing authorisation holder: HIKMA
- Local brand name: EMBELINE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 10 March 2008
- Application: ANDA077763
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CLOBETASOL PROPIONATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 4 December 2008
- Application: ANDA078223
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 7 June 2011
- Application: ANDA078854
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 16 June 2011
- Application: ANDA090898
- Marketing authorisation holder: PADAGIS US
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SPRAY — TOPICAL
- Status: approved
FDA — authorised 2 July 2012
- Application: ANDA200302
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOBETASOL PROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 9 August 2012
- Application: ANDA090974
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 23 November 2015
- Application: ANDA206075
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 29 November 2016
- Application: ANDA208667
- Marketing authorisation holder: BEACH PRODS
- Local brand name: CLOBETASOL PROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 16 February 2017
- Application: ANDA206378
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SPRAY — TOPICAL
- Status: approved
FDA — authorised 20 March 2017
- Application: ANDA208933
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 28 April 2017
- Application: ANDA207218
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SPRAY — TOPICAL
- Status: approved
FDA — authorised 31 July 2017
- Application: ANDA206805
- Marketing authorisation holder: NOVAST LABS
- Local brand name: CLOBETASOL PROPIONATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 21 August 2017
- Application: ANDA209411
- Marketing authorisation holder: BEACH PRODS
- Local brand name: CLOBETASOL PROPIONATE (EMOLLIENT)
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 22 September 2017
- Application: ANDA209147
- Marketing authorisation holder: LUPIN
- Local brand name: CLOBETASOL PROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 25 October 2017
- Application: ANDA209361
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 27 October 2017
- Application: ANDA210199
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 27 October 2017
- Application: ANDA209871
- Marketing authorisation holder: HIKMA
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 28 November 2017
- Application: NDA209483
- Marketing authorisation holder: PRIMUS PHARMS
- Local brand name: IMPOYZ
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 30 January 2018
- Application: ANDA210208
- Marketing authorisation holder: LUPIN
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 March 2018
- Application: ANDA209004
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SPRAY — TOPICAL
- Status: approved
FDA — authorised 26 March 2018
- Application: ANDA208842
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SPRAY — TOPICAL
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA209701
- Marketing authorisation holder: XIROMED
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA209974
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA210446
- Marketing authorisation holder: APOTEX
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SPRAY — TOPICAL
- Status: approved
FDA — authorised 18 April 2018
- Application: ANDA210190
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 4 May 2018
- Application: ANDA208841
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 10 May 2018
- Application: ANDA209095
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 15 June 2018
- Application: ANDA210034
- Marketing authorisation holder: XIROMED
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 21 August 2018
- Application: ANDA210551
- Marketing authorisation holder: AMNEAL
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 4 October 2018
- Application: ANDA208779
- Marketing authorisation holder: TARO
- Local brand name: CLOBETASOL PROPIONATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 15 October 2018
- Application: ANDA211074
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 October 2018
- Application: ANDA211348
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 26 December 2018
- Application: ANDA211256
- Marketing authorisation holder: AMNEAL
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 11 January 2019
- Application: ANDA211401
- Marketing authorisation holder: RISING
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 23 January 2019
- Application: ANDA208589
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 15 February 2019
- Application: ANDA210809
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: CLOBETASOL PROPIONATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 4 March 2019
- Application: ANDA211800
- Marketing authorisation holder: ALEMBIC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 9 September 2019
- Application: ANDA211450
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: CLOBETASOL PROPIONATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 24 September 2019
- Application: ANDA205249
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: CLOBETASOL PROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 2 October 2019
- Application: ANDA211494
- Marketing authorisation holder: SAPTALIS PHARMS
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 2 October 2019
- Application: ANDA211191
- Marketing authorisation holder: ALEMBIC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SPRAY — TOPICAL
- Status: approved
FDA — authorised 21 October 2019
- Application: ANDA212881
- Marketing authorisation holder: ALEMBIC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 25 October 2019
- Application: ANDA212926
- Marketing authorisation holder: TORRENT
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 30 December 2019
- Application: ANDA211836
- Marketing authorisation holder: TORRENT
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 27 January 2020
- Application: ANDA213291
- Marketing authorisation holder: ALEMBIC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 18 May 2020
- Application: ANDA213290
- Marketing authorisation holder: ALEMBIC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 19 May 2020
- Application: NDA213691
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: IMPEKLO
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 28 August 2020
- Application: ANDA212982
- Marketing authorisation holder: ENCUBE
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 8 February 2021
- Application: ANDA213139
- Marketing authorisation holder: PRINSTON INC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 25 March 2021
- Application: ANDA214867
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 26 March 2021
- Application: ANDA211207
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CLOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 14 June 2021
- Application: ANDA214895
- Marketing authorisation holder: AMNEAL
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 17 February 2022
- Application: ANDA211240
- Marketing authorisation holder: QUAGEN
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 21 April 2022
- Application: ANDA215838
- Marketing authorisation holder: ALEMBIC
- Local brand name: CLOBETASOL PROPIONATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 28 December 2023
- Application: ANDA215990
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: CLOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 4 March 2024
- Application: NDA218158
- Marketing authorisation holder: HARROW EYE
- Local brand name: BYQLOVI
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 14 March 2024
- Application: ANDA208563
- Marketing authorisation holder: TARO
- Local brand name: CLOBETASOL PROPIONATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 2 December 2024
- Application: ANDA214345
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: CLOBETASOL PROPIONATE
- Indication: SPRAY — TOPICAL
- Status: approved
FDA — authorised 20 November 2025
- Application: ANDA210638
- Marketing authorisation holder: XIROMED
- Local brand name: CLOBETASOL PROPIONATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
The FDA approved XIROMED's application (ANDA210638) for CLOBETASOL PROPIONATE topical steroid on November 20, 2025. This approval allows XIROMED to market and distribute the product in the United States. CLOBETASOL PROPIONATE is indicated for the treatment of various skin conditions, including inflammatory and pruritic dermatoses, when applied as an aerosol or foam.
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 60
Most-reported reactions
- Psoriasis — 13 reports (21.67%)
- Drug Ineffective — 9 reports (15%)
- Pruritus — 6 reports (10%)
- Corneal Opacity — 5 reports (8.33%)
- Headache — 5 reports (8.33%)
- Nausea — 5 reports (8.33%)
- Skin Exfoliation — 5 reports (8.33%)
- Arthralgia — 4 reports (6.67%)
- Condition Aggravated — 4 reports (6.67%)
- Insomnia — 4 reports (6.67%)
Other Dermatology approved in United States
Frequently asked questions
Is Topical steroid approved in United States?
Yes. FDA authorised it on 16 February 1994; FDA authorised it on 16 February 1994; FDA authorised it on 17 June 1994.
Who is the marketing authorisation holder for Topical steroid in United States?
TEVA PHARMS USA holds the US marketing authorisation.