FDA — authorised 8 June 1984
- Application: ANDA088676
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Glucocorticoids in United States
FDA authorised Glucocorticoids on 8 June 1984 · 194 US adverse-event reports
Marketing authorisations
FDA — authorised 22 February 1991
- Application: ANDA089575
- Marketing authorisation holder: ABBOTT
- Local brand name: A-METHAPRED
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 February 1991
- Application: ANDA089573
- Marketing authorisation holder: ABBOTT
- Local brand name: A-METHAPRED
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 February 1991
- Application: ANDA089576
- Marketing authorisation holder: ABBOTT
- Local brand name: A-METHAPRED
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 February 1991
- Application: ANDA089574
- Marketing authorisation holder: ABBOTT
- Local brand name: A-METHAPRED
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 November 1992
- Application: ANDA081267
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 November 1992
- Application: ANDA081266
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 November 1992
- Application: ANDA081268
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 July 2004
- Application: ANDA040583
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 August 2004
- Application: ANDA040612
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 February 2007
- Application: ANDA040641
- Marketing authorisation holder: BEDFORD LABS
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 February 2007
- Application: ANDA040662
- Marketing authorisation holder: BEDFORD LABS
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 November 2008
- Application: ANDA040827
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: A-METHAPRED
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 July 2011
- Application: ANDA040888
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 November 2016
- Application: ANDA207549
- Marketing authorisation holder: AMNEAL
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 April 2021
- Application: ANDA212396
- Marketing authorisation holder: TIANJIN KINGYORK
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA089267
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089266
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089265
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA087030
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088524
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088523
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088677
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088678
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088679
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA087852
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 194
Most-reported reactions
- Drug Ineffective — 30 reports (15.46%)
- Infection — 22 reports (11.34%)
- Arthralgia — 21 reports (10.82%)
- Pyrexia — 21 reports (10.82%)
- Pneumonia — 19 reports (9.79%)
- Diarrhoea — 18 reports (9.28%)
- Impaired Healing — 17 reports (8.76%)
- Dyspnoea — 16 reports (8.25%)
- Condition Aggravated — 15 reports (7.73%)
- Fatigue — 15 reports (7.73%)
Glucocorticoids in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Glucocorticoids approved in United States?
Yes. FDA authorised it on 8 June 1984; FDA authorised it on 22 February 1991; FDA authorised it on 22 February 1991.
Who is the marketing authorisation holder for Glucocorticoids in United States?
ABRAXIS PHARM holds the US marketing authorisation.