FDA — authorised 15 February 1980
- Application: ANDA086906
- Marketing authorisation holder: ELKINS SINN
- Local brand name: METHYLPREDNISOLONE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Corticosteroids (Prednisone) in United States
FDA authorised Corticosteroids (Prednisone) on 15 February 1980
Marketing authorisations
FDA — authorised 28 July 1981
- Application: ANDA087341
- Marketing authorisation holder: RISING
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 1982
- Application: ANDA086161
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 1982
- Application: ANDA086159
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 June 1982
- Application: ANDA087535
- Marketing authorisation holder: ORGANON USA INC
- Local brand name: METHYLPREDNISOLONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 April 1988
- Application: ANDA089208
- Marketing authorisation holder: PAR PHARM
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 April 1988
- Application: ANDA089209
- Marketing authorisation holder: PAR PHARM
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 April 1988
- Application: ANDA089207
- Marketing authorisation holder: PAR PHARM
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 1997
- Application: ANDA040232
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2018
- Application: ANDA206751
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2018
- Application: ANDA204072
- Marketing authorisation holder: TIANJIN TIANYAO
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 January 2019
- Application: ANDA210985
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 February 2019
- Application: ANDA209097
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 June 2019
- Application: ANDA212262
- Marketing authorisation holder: PRAXGEN
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 September 2021
- Application: ANDA207481
- Marketing authorisation holder: AMNEAL
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA060645
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: NEO-MEDROL
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA085650
- Marketing authorisation holder: HEATHER
- Local brand name: METHYLPREDNISOLONE
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is Corticosteroids (Prednisone) approved in United States?
Yes. FDA authorised it on 15 February 1980; FDA authorised it on 28 July 1981; FDA authorised it on 9 February 1982.
Who is the marketing authorisation holder for Corticosteroids (Prednisone) in United States?
ELKINS SINN holds the US marketing authorisation.