FDA — authorised 21 December 1951
- Marketing authorisation holder: MERCK
- Status: approved
🇺🇸 Cortifoam in United States
FDA authorised Cortifoam on 21 December 1951
Marketing authorisations
FDA — authorised 28 July 1953
- Application: NDA008917
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: CORTEF ACETATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 16 April 1964
- Application: NDA050356
- Marketing authorisation holder: PH HEALTH
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 18 May 1965
- Application: ANDA060751
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: NEO-CORTEF
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 26 October 1968
- Application: ANDA060188
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: COR-OTICIN
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 18 September 1969
- Application: ANDA061016
- Marketing authorisation holder: PFIZER
- Local brand name: TERRA-CORTRIL
- Indication: SUSPENSION — OPHTHALMIC
- Status: approved
FDA — authorised 12 January 1973
- Application: ANDA080505
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CARMOL HC
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 6 March 1973
- Application: ANDA083205
- Marketing authorisation holder: COLGATE
- Local brand name: ORABASE HCA
- Indication: PASTE — TOPICAL
- Status: approved
FDA — authorised 13 November 1973
- Application: ANDA083213
- Marketing authorisation holder: FERNDALE LABS
- Local brand name: PRAMOSONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 21 January 1974
- Application: ANDA083739
- Marketing authorisation holder: BEL MAR
- Local brand name: HYDROCORTISONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 May 1976
- Application: ANDA080828
- Marketing authorisation holder: FERA PHARMS
- Local brand name: HYDROCORTISONE ACETATE
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 13 August 1976
- Application: ANDA083778
- Marketing authorisation holder: LEGACY PHARMA
- Local brand name: PRAMOSONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 7 January 1977
- Application: ANDA085368
- Marketing authorisation holder: LEGACY PHARMA
- Local brand name: PRAMOSONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 15 March 1977
- Application: NDA009378
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: CORTEF ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 May 1978
- Application: ANDA085981
- Marketing authorisation holder: X GEN PHARMS
- Local brand name: HYDROCORTISONE ACETATE
- Indication: POWDER — FOR RX COMPOUNDING
- Status: approved
FDA — authorised 5 June 1978
- Application: ANDA085979
- Marketing authorisation holder: LEGACY PHARMA
- Local brand name: PRAMOSONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 5 June 1978
- Application: ANDA085980
- Marketing authorisation holder: LEGACY PHARMA
- Local brand name: PRAMOSONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 27 February 1979
- Application: ANDA083128
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROCORTISONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 December 1979
- Application: ANDA086457
- Marketing authorisation holder: MYLAN SPECIALITY LP
- Local brand name: EPIFOAM
- Indication: AEROSOL, METERED — TOPICAL
- Status: approved
FDA — authorised 14 April 1981
- Application: ANDA062166
- Marketing authorisation holder: PADAGIS US
- Local brand name: BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 26 October 1981
- Application: NDA009637
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: HYDROCORTISONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 February 1982
- Application: NDA017351
- Marketing authorisation holder: VIATRIS
- Local brand name: CORTIFOAM
- Indication: AEROSOL, METERED — RECTAL
- Status: approved
FDA — authorised 3 June 1982
- Application: ANDA086050
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: HYDROCORTISONE ACETATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 17 May 1988
- Application: ANDA089440
- Marketing authorisation holder: GENUS
- Local brand name: HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%
- Indication: AEROSOL, METERED — TOPICAL
- Status: approved
FDA — authorised 13 June 1988
- Application: ANDA089472
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: U-CORT
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 28 August 1990
- Application: ANDA086195
- Marketing authorisation holder: MYLAN SPECIALITY LP
- Indication: Labeling
- Status: approved
FDA — authorised 29 July 1999
- Application: ANDA040259
- Marketing authorisation holder: IMPERIUM
- Local brand name: HYDROCORTISONE ACETATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 27 February 2001
- Application: ANDA040396
- Marketing authorisation holder: LEGACY PHARMA
- Local brand name: MICORT-HC
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 29 March 2002
- Application: ANDA040398
- Marketing authorisation holder: LEGACY PHARMA
- Local brand name: MICORT-HC
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA061049
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: NEO-CORTEF
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA086052
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: HYDROCORTISONE ACETATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA085214
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROCORTISONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA081274
- Marketing authorisation holder: ABLE
- Local brand name: HEMSOL-HC
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA060731
- Marketing authorisation holder: ALTANA
- Local brand name: BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA060612
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: NEO-CORTEF
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA060610
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: NEO-CORTEF
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA086207
- Marketing authorisation holder: INGRAM PHARM
- Local brand name: DRICORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA
- Application: ANDA089914
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: HYDROCORTISONE ACETATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA080419
- Marketing authorisation holder: CENCI
- Local brand name: HYDROCORTISONE ACETATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: NDA009164
- Marketing authorisation holder: PFIZER
- Local brand name: CORTRIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA083759
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROCORTISONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Cortifoam 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 Cortifoam approved in United States?
Yes. FDA authorised it on 21 December 1951; FDA authorised it on 28 July 1953; FDA authorised it on 16 April 1964.
Who is the marketing authorisation holder for Cortifoam in United States?
MERCK holds the US marketing authorisation.