FDA — authorised 3 December 1953
- Application: NDA009127
- Marketing authorisation holder: PFIZER
- Local brand name: CORTRIL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 corticosteroids only in United States
FDA authorised corticosteroids only on 3 December 1953
Marketing authorisations
FDA — authorised 19 January 1955
- Application: NDA009659
- Marketing authorisation holder: PANRAY
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 1955
- Application: NDA009866
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: SOLU-CORTEF
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 October 1964
- Application: NDA050237
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: NEO-CORT-DOME
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 22 December 1971
- Application: ANDA080425
- Marketing authorisation holder: MISSION PHARMA
- Local brand name: TEXACORT
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 4 April 1972
- Application: ANDA080442
- Marketing authorisation holder: BAUSCH
- Local brand name: NUTRACORT
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 April 1972
- Application: ANDA080443
- Marketing authorisation holder: DOW PHARM
- Local brand name: NUTRACORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 1 May 1972
- Application: ANDA080568
- Marketing authorisation holder: FERRANTE
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 May 1972
- Application: NDA009176
- Marketing authorisation holder: PFIZER GLOBAL
- Local brand name: CORTRIL
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 15 September 1972
- Application: ANDA080400
- Marketing authorisation holder: TEVA
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 25 September 1972
- Application: ANDA080473
- Marketing authorisation holder: VALEANT INTL
- Local brand name: HYTONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 26 September 1972
- Application: ANDA080474
- Marketing authorisation holder: DERMIK LABS
- Local brand name: HYTONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 27 September 1972
- Application: ANDA080472
- Marketing authorisation holder: VALEANT INTL
- Local brand name: HYTONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 11 October 1972
- Application: ANDA061606
- Marketing authorisation holder: FOREST LABS
- Local brand name: PYOCIDIN
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 28 February 1973
- Application: ANDA083201
- Marketing authorisation holder: CROWN LABS
- Local brand name: ALA-CORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 28 February 1973
- Application: ANDA083231
- Marketing authorisation holder: LEGACY PHARMA
- Local brand name: ALA-SCALP
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 9 March 1973
- Application: ANDA080706
- Marketing authorisation holder: CROWN LABS
- Local brand name: ALA-CORT
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 9 March 1973
- Application: ANDA083140
- Marketing authorisation holder: NEXGEN PHARMA INC
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 March 1973
- Application: ANDA080481
- Marketing authorisation holder: C AND M PHARMA
- Local brand name: HC (HYDROCORTISONE)
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 20 March 1973
- Application: ANDA080483
- Marketing authorisation holder: C AND M PHARMA
- Local brand name: HI-COR
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 20 March 1973
- Application: ANDA080482
- Marketing authorisation holder: C AND M PHARMA
- Local brand name: HC (HYDROCORTISONE)
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 April 1973
- Application: ANDA083011
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: DERMACORT
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 18 May 1973
- Application: ANDA080496
- Marketing authorisation holder: WHITEWORTH TOWN PLSN
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 18 June 1973
- Application: ANDA083365
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 March 1974
- Application: ANDA083999
- Marketing authorisation holder: BARR
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 1974
- Application: ANDA080642
- Marketing authorisation holder: SANDOZ
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 1975
- Application: ANDA080692
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 25 May 1975
- Application: NDA060613
- Marketing authorisation holder: CASPER PHARMA LLC
- Local brand name: CASPORYN HC
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
FDA — authorised 6 January 1976
- Application: ANDA084698
- Marketing authorisation holder: HEALTHPOINT
- Local brand name: NUTRACORT
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 30 April 1976
- Application: ANDA080693
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 7 May 1976
- Application: ANDA085070
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 1977
- Application: ANDA085492
- Marketing authorisation holder: KV PHARM
- Local brand name: ACETIC ACID W/ HYDROCORTISONE
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 30 November 1977
- Application: ANDA085027
- Marketing authorisation holder: PADAGIS US
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 20 January 1978
- Application: ANDA086008
- Marketing authorisation holder: BIOGLAN
- Local brand name: ALPHADERM
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 April 1978
- Application: ANDA086080
- Marketing authorisation holder: AMBIX
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 9 May 1978
- Application: ANDA085982
- Marketing authorisation holder: X GEN PHARMS
- Local brand name: HYDRO-RX
- Indication: POWDER — FOR RX COMPOUNDING
- Status: approved
FDA — authorised 11 May 1978
- Application: ANDA086079
- Marketing authorisation holder: AMBIX
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 5 June 1978
- Application: ANDA085282
- Marketing authorisation holder: MERICON
- Local brand name: HYDROCORTISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 24 July 1978
- Application: ANDA086257
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 24 July 1978
- Application: ANDA086155
- Marketing authorisation holder: TARO
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 6 November 1978
- Application: ANDA085733
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 29 August 1980
- Application: NDA050272
- Marketing authorisation holder: LEDERLE
- Local brand name: ACHROMYCIN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 4 February 1981
- Application: ANDA086535
- Marketing authorisation holder: BAKER NORTON
- Local brand name: ACTICORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 1 December 1981
- Application: ANDA062302
- Marketing authorisation holder: SCHERING
- Local brand name: OTOBIOTIC
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 24 May 1982
- Application: ANDA086256
- Marketing authorisation holder: TARO
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 2 June 1982
- Application: ANDA085025
- Marketing authorisation holder: PADAGIS US
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 4 June 1982
- Application: ANDA086154
- Marketing authorisation holder: TARO
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 7 June 1982
- Application: ANDA087317
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: HYDROCORTISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 7 June 1982
- Application: ANDA087315
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: HYDROCORTISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 7 June 1982
- Application: ANDA080489
- Marketing authorisation holder: ALTANA
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 1 July 1982
- Application: ANDA080459
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: ELDECORT
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 24 August 1982
- Application: ANDA087644
- Marketing authorisation holder: DOW PHARM
- Local brand name: NUTRACORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 13 October 1982
- Application: ANDA087796
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 3 December 1982
- Application: ANDA088041
- Marketing authorisation holder: SOLVAY
- Local brand name: BALNEOL-HC
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 8 April 1983
- Application: ANDA088082
- Marketing authorisation holder: PADDOCK LLC
- Local brand name: HYDROCORTISONE
- Indication: POWDER — FOR RX COMPOUNDING
- Status: approved
FDA — authorised 3 May 1983
- Application: ANDA087795
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 27 September 1983
- Application: ANDA088039
- Marketing authorisation holder: USL PHARMA
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 27 September 1983
- Application: ANDA088061
- Marketing authorisation holder: USL PHARMA
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 3 October 1983
- Application: ANDA087489
- Marketing authorisation holder: HERAN
- Local brand name: GLYCORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 6 June 1984
- Application: ANDA088214
- Marketing authorisation holder: ALLERGAN HERBERT
- Local brand name: PENECORT
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 6 June 1984
- Application: ANDA088250
- Marketing authorisation holder: SALIX PHARMS
- Local brand name: ANUSOL HC
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 6 June 1984
- Application: ANDA088216
- Marketing authorisation holder: ALLERGAN HERBERT
- Local brand name: PENECORT
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 6 September 1985
- Application: ANDA088138
- Marketing authorisation holder: CMP PHARMA INC
- Local brand name: HYDROCORTISONE IN ABSORBASE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 6 November 1985
- Application: ANDA062488
- Marketing authorisation holder: SANDOZ
- Local brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
FDA — authorised 25 November 1985
- Application: ANDA089066
- Marketing authorisation holder: PADAGIS US
- Local brand name: STIE-CORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 26 November 1985
- Application: ANDA089074
- Marketing authorisation holder: PADAGIS US
- Local brand name: STIE-CORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 12 February 1986
- Application: ANDA089024
- Marketing authorisation holder: TARO
- Local brand name: HYDROCORTISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 16 December 1986
- Application: ANDA089414
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 9 February 1987
- Application: ANDA088842
- Marketing authorisation holder: PHARMADERM
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 25 January 1988
- Application: ANDA089495
- Marketing authorisation holder: BETA DERMAC
- Local brand name: BETA-HC
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 10 March 1988
- Application: ANDA089682
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 10 March 1988
- Application: ANDA089706
- Marketing authorisation holder: NASKA
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 10 March 1988
- Application: ANDA089704
- Marketing authorisation holder: NASKA
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 25 April 1988
- Application: ANDA089705
- Marketing authorisation holder: NASKA
- Local brand name: HYDROCORTISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 11 May 1988
- Application: ANDA062874
- Marketing authorisation holder: SANDOZ
- Local brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 17 February 1989
- Application: ANDA089273
- Marketing authorisation holder: TOPIDERM
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 17 April 1992
- Application: ANDA081271
- Marketing authorisation holder: MISSION PHARMA
- Local brand name: TEXACORT
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 28 May 1993
- Application: ANDA081203
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 27 May 1994
- Application: ANDA074171
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: HYDROCORTISONE
- Indication: ENEMA — RECTAL
- Status: approved
FDA — authorised 29 December 1995
- Application: ANDA064053
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 23 July 1999
- Application: ANDA040247
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: HYDROCORTISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 3 December 1999
- Application: ANDA075172
- Marketing authorisation holder: CHARTWELL
- Local brand name: COLOCORT
- Indication: ENEMA — RECTAL
- Status: approved
FDA — authorised 25 July 2000
- Application: ANDA040351
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: HYDROCORTISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 29 December 2000
- Application: ANDA040310
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 30 July 2003
- Application: ANDA040417
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: HYDROCORTISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 12 March 2004
- Application: ANDA040503
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 30 March 2007
- Application: ANDA040646
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 July 2007
- Application: ANDA040761
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 August 2010
- Application: ANDA040879
- Marketing authorisation holder: RISING
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 23 July 2018
- Application: ANDA203810
- Marketing authorisation holder: ENCUBE
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 27 July 2018
- Application: ANDA203804
- Marketing authorisation holder: ENCUBE
- Local brand name: HYDROCORTISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 29 September 2020
- Application: NDA213876
- Marketing authorisation holder: ETON
- Local brand name: ALKINDI SPRINKLE
- Indication: GRANULE — ORAL
- Status: approved
FDA — authorised 25 November 2024
- Application: ANDA217160
- Marketing authorisation holder: HIBROW HLTHCARE
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 May 2025
- Application: ANDA217881
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 May 2025
- Application: NDA218980
- Marketing authorisation holder: ETON
- Local brand name: KHINDIVI
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 September 2025
- Application: ANDA217735
- Marketing authorisation holder: AMNEAL
- Local brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
FDA — authorised 29 October 2025
- Application: ANDA217803
- Marketing authorisation holder: AMNEAL
- Local brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 25 February 2026
- Application: ANDA220329
- Marketing authorisation holder: APPCO
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088029
- Marketing authorisation holder: USL PHARMA
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA084247
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085191
- Marketing authorisation holder: TEVA
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA085028
- Marketing authorisation holder: PERRIGO NEW YORK
- Local brand name: HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Application: ANDA085663
- Marketing authorisation holder: PERRIGO NEW YORK
- Local brand name: HYDROCORTISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA
- Application: ANDA085026
- Marketing authorisation holder: PERRIGO NEW YORK
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA085662
- Marketing authorisation holder: PERRIGO NEW YORK
- Local brand name: HYDROCORTISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA
- Application: ANDA083219
- Marketing authorisation holder: BLULINE
- Local brand name: EPICORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA
- Application: ANDA088217
- Marketing authorisation holder: ALLERGAN HERBERT
- Local brand name: PENECORT
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Application: ANDA088215
- Marketing authorisation holder: ALLERGAN HERBERT
- Local brand name: PENECORT
- Indication: GEL — TOPICAL
- Status: approved
FDA
- Application: ANDA088539
- Marketing authorisation holder: ROXANE
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088845
- Marketing authorisation holder: PHARMADERM
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA080438
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: HC #4
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA089413
- Marketing authorisation holder: PHARMADERM
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA084055
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: ELDECORT
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA062623
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA080395
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084059
- Marketing authorisation holder: G AND W LABS
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA083947
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: CALMURID HC
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA080732
- Marketing authorisation holder: INWOOD LABS
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080781
- Marketing authorisation holder: IMPAX LABS
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085527
- Marketing authorisation holder: SYOSSET
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA080624
- Marketing authorisation holder: ELKINS SINN
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086823
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: H-CORT
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA080456
- Marketing authorisation holder: INGRAM PHARM
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA086824
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: H-CORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA
- Application: ANDA084573
- Marketing authorisation holder: SOLVAY
- Local brand name: DERMACORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA
- Application: ANDA086462
- Marketing authorisation holder: SOLVAY
- Local brand name: DERMACORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA
- Application: ANDA062521
- Marketing authorisation holder: WATSON LABS
- Local brand name: OTOCORT
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
FDA
- Application: ANDA080452
- Marketing authorisation holder: EVERYLIFE
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA062399
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: OTICAIR
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
FDA
- Application: ANDA060730
- Marketing authorisation holder: WATSON LABS
- Local brand name: OTOCORT
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA
- Application: ANDA089754
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA062394
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA
- Application: ANDA087136
- Marketing authorisation holder: WESTWOOD SQUIBB
- Local brand name: FLEXICORT
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA084243
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: HYDROCORTISONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086170
- Marketing authorisation holder: STIEFEL
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA088027
- Marketing authorisation holder: USL PHARMA
- Local brand name: HYDROCORTISONE
- Indication: CREAM — TOPICAL
- Status: approved
corticosteroids only in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is corticosteroids only approved in United States?
Yes. FDA authorised it on 3 December 1953; FDA authorised it on 19 January 1955; FDA authorised it on 27 April 1955.
Who is the marketing authorisation holder for corticosteroids only in United States?
PFIZER holds the US marketing authorisation.