FDA — authorised 15 February 1980
- Application: ANDA086906
- Marketing authorisation holder: ELKINS SINN
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Combined with voriconazole in United States
FDA authorised Combined with voriconazole on 15 February 1980
Marketing authorisations
FDA — authorised 8 June 1984
- Application: ANDA088676
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- 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: ANDA089575
- 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: 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 November 1992
- Application: ANDA081267
- 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 20 December 2005
- Application: ANDA040664
- Marketing authorisation holder: HOSPIRA
- Local brand name: A-METHAPRED
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 December 2005
- Application: ANDA040665
- Marketing authorisation holder: HOSPIRA
- Local brand name: A-METHAPRED
- 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: ANDA040709
- 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 21 August 2012
- Application: ANDA091558
- Marketing authorisation holder: APOTEX INC
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 8 January 2014
- Application: ANDA091248
- Marketing authorisation holder: RK PHARMA
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 30 October 2014
- Application: ANDA202720
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 15 December 2015
- Application: ANDA207667
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 February 2016
- Application: ANDA202691
- Marketing authorisation holder: HIKMA
- 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 23 August 2017
- Application: ANDA202555
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 13 December 2019
- Application: ANDA211173
- Marketing authorisation holder: CONCORD BIOTECH LTD
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 10 February 2021
- Application: ANDA214376
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- 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 — authorised 23 September 2021
- Application: ANDA208315
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 29 November 2021
- Application: ANDA214630
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 29 November 2023
- Application: ANDA217031
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 29 May 2024
- Application: ANDA216637
- Marketing authorisation holder: FOSUN WANBANG
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA088679
- 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: 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: ANDA089264
- 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: ANDA087852
- Marketing authorisation holder: INTL MEDICATION
- 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: ANDA089267
- Marketing authorisation holder: QUAD PHARMS
- 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
Other Infectious Diseases approved in United States
Frequently asked questions
Is Combined with voriconazole approved in United States?
Yes. FDA authorised it on 15 February 1980; FDA authorised it on 8 June 1984; FDA authorised it on 22 February 1991.
Who is the marketing authorisation holder for Combined with voriconazole in United States?
ELKINS SINN holds the US marketing authorisation.