FDA — authorised 27 May 1959
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
🇺🇸 Depo-Medrol in United States
FDA authorised Depo-Medrol on 27 May 1959
Marketing authorisations
FDA — authorised 27 May 1959
- Application: NDA011757
- Marketing authorisation holder: PFIZER
- Local brand name: DEPO-MEDROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 December 1964
- Application: ANDA060611
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: NEO-MEDROL ACETATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 14 March 1979
- Application: ANDA085600
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 March 1979
- Application: ANDA085597
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 March 1979
- Application: ANDA085595
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 December 1979
- Application: ANDA086666
- Marketing authorisation holder: BEL MAR
- Local brand name: M-PREDROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 January 1981
- Application: ANDA087135
- Marketing authorisation holder: BEL MAR
- Local brand name: M-PREDROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 February 2005
- Application: ANDA040557
- Marketing authorisation holder: HONG KONG
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 October 2006
- Application: ANDA040620
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 January 2009
- Application: ANDA040719
- Marketing authorisation holder: SANDOZ
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 June 2018
- Application: ANDA201835
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 May 2019
- Application: ANDA210043
- Marketing authorisation holder: AMNEAL
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Depo-Medrol for use in the United States on 2024-05-07. The marketing authorisation holder is AMNEAL. The approval was granted under the standard expedited pathway. Depo-Medrol is indicated for use as stated in its labelling.
FDA — authorised 21 January 2022
- Application: ANDA214297
- Marketing authorisation holder: PH HEALTH
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 January 2023
- Application: ANDA214870
- Marketing authorisation holder: WILSHIRE PHARMS INC
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 April 2023
- Application: ANDA211930
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 3 November 2023
- Application: ANDA216502
- Marketing authorisation holder: AMNEAL
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 January 2026
- Application: ANDA220556
- Marketing authorisation holder: CAPLIN
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA086903
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA086507
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA087248
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLPREDNISOLONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Depo-Medrol 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 Depo-Medrol approved in United States?
Yes. FDA authorised it on 27 May 1959; FDA authorised it on 27 May 1959; FDA authorised it on 7 December 1964.
Who is the marketing authorisation holder for Depo-Medrol in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.