FDA — authorised 10 August 1959
- Application: NDA011719
- Marketing authorisation holder: HOSPIRA
- Local brand name: METHOTREXATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Methotrexate (MTX) in United States
FDA authorised Methotrexate (MTX) on 10 August 1959
Marketing authorisations
FDA — authorised 9 May 1986
- Application: ANDA088648
- Marketing authorisation holder: NORBROOK
- Local brand name: METHOTREXATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 June 1986
- Application: ANDA089323
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: METHOTREXATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 June 1986
- Application: ANDA089263
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: METHOTREXATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 June 1986
- Application: ANDA089322
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: METHOTREXATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 September 1986
- Application: ANDA089342
- Marketing authorisation holder: HIKMA
- Local brand name: METHOTREXATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 September 1986
- Application: ANDA089340
- Marketing authorisation holder: HIKMA
- Local brand name: METHOTREXATE SODIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 September 1986
- Application: ANDA089341
- Marketing authorisation holder: HIKMA
- Local brand name: METHOTREXATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 September 1986
- Application: ANDA089343
- Marketing authorisation holder: HIKMA
- Local brand name: METHOTREXATE SODIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 August 1987
- Application: ANDA088937
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: METHOTREXATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 August 1987
- Application: ANDA088935
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: METHOTREXATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 August 1987
- Application: ANDA088936
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: METHOTREXATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 April 1989
- Application: ANDA089887
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: MEXATE-AQ PRESERVED
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 October 1990
- Application: ANDA081099
- Marketing authorisation holder: BARR
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 1991
- Application: ANDA081242
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: FOLEX PFS
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 November 1991
- Application: NDA020079
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: METHOTREXATE SODIUM
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 15 May 1992
- Application: ANDA081235
- Marketing authorisation holder: MYLAN
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 August 1994
- Application: ANDA040054
- Marketing authorisation holder: HIKMA
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 1999
- Application: ANDA040266
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: METHOTREXATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 February 1999
- Application: ANDA040263
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: METHOTREXATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 February 1999
- Application: ANDA040265
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: METHOTREXATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 June 1999
- Application: ANDA040233
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 August 2005
- Application: ANDA040632
- Marketing authorisation holder: HIKMA
- Local brand name: METHOTREXATE SODIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 April 2007
- Application: ANDA040716
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: METHOTREXATE SODIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 March 2009
- Application: ANDA090029
- Marketing authorisation holder: CAPLIN ONE LABS
- Local brand name: METHOTREXATE SODIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 January 2010
- Application: ANDA040843
- Marketing authorisation holder: PHARMACHEMIE BV
- Local brand name: METHOTREXATE SODIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 March 2012
- Application: ANDA201530
- Marketing authorisation holder: EXTROVIS
- Local brand name: METHOTREXATE SODIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 March 2012
- Application: ANDA201529
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: METHOTREXATE SODIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 May 2015
- Application: ANDA201749
- Marketing authorisation holder: SUN PHARM
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 January 2017
- Application: ANDA207812
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 April 2017
- Application: NDA208400
- Marketing authorisation holder: AZURITY
- Local brand name: XATMEP
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 22 December 2017
- Application: ANDA210040
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 August 2018
- Application: ANDA203407
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: METHOTREXATE SODIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 January 2020
- Application: ANDA213343
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 January 2020
- Application: ANDA210454
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2021
- Application: ANDA209787
- Marketing authorisation holder: LOTUS PHARM CO LTD
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 August 2023
- Application: ANDA213362
- Marketing authorisation holder: DAITO
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 May 2024
- Application: ANDA216453
- Marketing authorisation holder: ELITE LABS INC
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2024
- Application: ANDA217552
- Marketing authorisation holder: ALEMBIC
- Local brand name: METHOTREXATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 2026
- Application: ANDA220225
- Marketing authorisation holder: ALEMBIC
- Local brand name: METHOTREXATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089356
- Marketing authorisation holder: ABIC
- Local brand name: ABITREXATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089355
- Marketing authorisation holder: ABIC
- Local brand name: ABITREXATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089354
- Marketing authorisation holder: ABIC
- Local brand name: ABITREXATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089293
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: METHOTREXATE SODIUM
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089295
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: METHOTREXATE SODIUM
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089296
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: METHOTREXATE SODIUM
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089308
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: METHOTREXATE SODIUM
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089309
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: METHOTREXATE SODIUM
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089294
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: METHOTREXATE SODIUM
- Indication: Injectable — Injection
- Status: approved
Frequently asked questions
Is Methotrexate (MTX) approved in United States?
Yes. FDA authorised it on 10 August 1959; FDA authorised it on 9 May 1986; FDA authorised it on 13 June 1986.
Who is the marketing authorisation holder for Methotrexate (MTX) in United States?
HOSPIRA holds the US marketing authorisation.