FDA — authorised 24 October 1957
- Application: NDA011153
- Marketing authorisation holder: PFIZER
- Local brand name: MEDROL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Medrol in United States
FDA authorised Medrol on 24 October 1957
Marketing authorisations
FDA — authorised 18 May 1959
- Application: NDA011856
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: SOLU-MEDROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 March 1998
- Application: ANDA040189
- Marketing authorisation holder: JUBILANT CADISTA
- Indication: Labeling
- Status: approved
FDA — authorised 23 December 2019
- Application: ANDA202691
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 2 April 2020
- Application: ANDA207667
- Marketing authorisation holder: EUGIA PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 12 December 2023
- Application: ANDA201835
- Marketing authorisation holder: SAGENT PHARMS INC
- Indication: Labeling
- Status: approved
FDA — authorised 11 October 2024
- Application: ANDA209097
- Marketing authorisation holder: CHARTWELL RX
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to Medrol on 11 October 2024. This decision was made under the standard expedited pathway. The marketing authorisation holder is Chartwell RX. The approved indication for Medrol is listed in its labelling.
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 Medrol approved in United States?
Yes. FDA authorised it on 24 October 1957; FDA authorised it on 18 May 1959; FDA authorised it on 19 March 1998.
Who is the marketing authorisation holder for Medrol in United States?
PFIZER holds the US marketing authorisation.