FDA — authorised 21 June 1955
- Application: NDA009987
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: DELTA-CORTEF
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 peroral methylprednisolone and Methotrexate in United States
FDA authorised peroral methylprednisolone and Methotrexate on 21 June 1955
Marketing authorisations
FDA — authorised 24 February 1956
- Application: NDA010209
- Marketing authorisation holder: SCHERING
- Local brand name: METI-DERM
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 9 May 1972
- Application: ANDA080562
- Marketing authorisation holder: FERRANTE
- Local brand name: PREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 1974
- Application: ANDA080531
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: PREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 June 1976
- Application: ANDA085085
- Marketing authorisation holder: WATSON LABS
- Local brand name: PREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 1985
- Application: ANDA088892
- Marketing authorisation holder: SUPERPHARM
- Local brand name: PREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 May 1999
- Application: ANDA040323
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PREDNISOLONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 28 May 1999
- Application: ANDA040287
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: PREDNISOLONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 19 January 2000
- Application: ANDA040322
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: PREDNISOLONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 10 April 2002
- Application: ANDA040364
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: PREDNISOLONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 10 September 2003
- Application: ANDA040313
- Marketing authorisation holder: PHARMOBEDIENT CNSLTG
- Local brand name: PREDNISOLONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 25 August 2005
- Application: ANDA040571
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: PREDNISOLONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 25 August 2005
- Application: ANDA040570
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: PREDNISOLONE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 17 March 2023
- Application: ANDA215673
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: PREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2025
- Application: ANDA219509
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: PREDNISOLONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA080534
- Marketing authorisation holder: VITARINE
- Local brand name: PREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083941
- Marketing authorisation holder: FERNDALE LABS
- Local brand name: FERNISOLONE-P
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080398
- Marketing authorisation holder: TEVA
- Local brand name: PREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084542
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA087987
- Marketing authorisation holder: UDL
- Local brand name: PREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080625
- Marketing authorisation holder: ELKINS SINN
- Local brand name: PREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085170
- Marketing authorisation holder: TABLICAPS
- Local brand name: PREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
peroral methylprednisolone and Methotrexate 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 peroral methylprednisolone and Methotrexate approved in United States?
Yes. FDA authorised it on 21 June 1955; FDA authorised it on 24 February 1956; FDA authorised it on 9 May 1972.
Who is the marketing authorisation holder for peroral methylprednisolone and Methotrexate in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.