FDA — authorised 22 May 1955
- Application: NDA010255
- Marketing authorisation holder: SCHERING
- Local brand name: METICORTELONE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Prednisolone Acetate 1% Oph Susp in United States
FDA authorised Prednisolone Acetate 1% Oph Susp 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 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 12 June 1975
- Application: ANDA084492
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: PREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- 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 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: 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
Other Ophthalmology approved in United States
Frequently asked questions
Is Prednisolone Acetate 1% Oph Susp approved in United States?
Yes. FDA authorised it on 22 May 1955; FDA authorised it on 23 June 1965; FDA authorised it on 10 July 1973.
Who is the marketing authorisation holder for Prednisolone Acetate 1% Oph Susp in United States?
SCHERING holds the US marketing authorisation.