FDA — authorised 22 May 1955
- Application: NDA010255
- Marketing authorisation holder: SCHERING
- Local brand name: METICORTELONE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Topical Prednisolone Acetate Ophthalmic Drops in United States
FDA authorised Topical Prednisolone Acetate Ophthalmic Drops on 22 May 1955
Marketing authorisations
FDA — authorised 23 June 1965
- Application: NDA010210
- Marketing authorisation holder: SCHERING
- Local brand name: METIMYD
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 10 November 1972
- Application: NDA017100
- Marketing authorisation holder: ABBVIE
- Local brand name: PRED MILD
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 10 July 1973
- Application: NDA017468
- Marketing authorisation holder: HARROW EYE
- Local brand name: ECONOPRED
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 13 February 1974
- Application: ANDA083398
- Marketing authorisation holder: WATSON LABS
- Local brand name: PREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 February 1974
- Application: ANDA083764
- Marketing authorisation holder: WATSON LABS
- Local brand name: PREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 March 1974
- Application: ANDA083738
- Marketing authorisation holder: BEL MAR
- Local brand name: PREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 June 1975
- Application: ANDA084492
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: PREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 July 1981
- Application: ANDA087547
- Marketing authorisation holder: ALCON
- Local brand name: ISOPTO CETAPRED
- Indication: SUSPENSION — OPHTHALMIC
- Status: approved
FDA — authorised 28 December 1982
- Application: ANDA088089
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: SULPHRIN
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 19 April 1983
- Application: ANDA088007
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: PREDSULFAIR
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 29 July 1983
- Application: ANDA088059
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: PREDAMIDE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 December 1986
- Application: ANDA087748
- Marketing authorisation holder: ALLERGAN
- Local brand name: BLEPHAMIDE S.O.P.
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 6 August 1993
- Application: ANDA087771
- Marketing authorisation holder: ALCON
- Local brand name: CETAPRED
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 12 May 1998
- Application: NDA011446
- Marketing authorisation holder: PFIZER
- Local brand name: STERANE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 January 2008
- Application: NDA022067
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: FLO-PRED
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 2 August 2024
- Application: ANDA216935
- Marketing authorisation holder: LUPIN
- Local brand name: PREDNISOLONE ACETATE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 11 June 2025
- Application: ANDA218256
- Marketing authorisation holder: AMNEAL
- Local brand name: PREDNISOLONE ACETATE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA083767
- Marketing authorisation holder: WATSON LABS
- Local brand name: PREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA088837
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: PREDSULFAIR II
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA084717
- Marketing authorisation holder: CENT PHARMS
- Local brand name: PREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088032
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: PREDSULFAIR
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA083032
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: PREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA083654
- Marketing authorisation holder: WATSON LABS
- Local brand name: PREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA085781
- Marketing authorisation holder: WATSON LABS
- Local brand name: PREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Topical Prednisolone Acetate Ophthalmic Drops 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 Topical Prednisolone Acetate Ophthalmic Drops approved in United States?
Yes. FDA authorised it on 22 May 1955; FDA authorised it on 23 June 1965; FDA authorised it on 10 November 1972.
Who is the marketing authorisation holder for Topical Prednisolone Acetate Ophthalmic Drops in United States?
SCHERING holds the US marketing authorisation.