Treats acute lymphoblastic leukemia. NDA 11719, held by Hospira. Methotrexate Sodium.
As of Nov 14, 2026, NDA 11719 (Methotrexate Sodium, Methotrexate Lpf, Methotrexate Sodium Preservative Free), held by Hospira, was first approved by FDA on Aug 10, 1959, with 73 approved supplements and 0 published complete response letters.
Methotrexate Injection is a folate analog metabolic inhibitor indicated for:
| Mar 29, 2021 | Supplement 131Efficacy (new indication or use) · Standard review | Approved | |
| Apr 7, 1988 | Supplement 77Efficacy (new indication or use) | Approved | None posted |
| Aug 10, 1959 | Original applicationNew active ingredient · Standard review | Approved | None posted |
| Methotrexate SodiumEQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Methotrexate Sodium | DiscontinuedReference drug |
| Methotrexate SodiumEQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Methotrexate Sodium | DiscontinuedReference drug |
| Methotrexate SodiumEQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Methotrexate Sodium | DiscontinuedReference drug |
| Methotrexate SodiumEQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Methotrexate Sodium | DiscontinuedReference drug |
| Methotrexate SodiumEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Methotrexate Sodium | DiscontinuedReference drug |
| Methotrexate LpfEQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Methotrexate Sodium | DiscontinuedReference drug |
| Methotrexate Sodium Preservative FreeEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Methotrexate Sodium | DiscontinuedReference drug |
| Methotrexate SodiumEQ 50MG BASE/2ML (EQ 25MG BASE/ML) · injectable;injection | Methotrexate Sodium | RxReference drug |
| Methotrexate Preservative FreeEQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Methotrexate Sodium | DiscontinuedReference drug |
| Methotrexate Sodium Preservative FreeEQ 1GM BASE/40ML (EQ 25MG BASE/ML) · injectable;injection | Methotrexate Sodium | RxReference drug |
| Methotrexate Preservative FreeEQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Methotrexate Sodium | DiscontinuedReference drug |
| Methotrexate Preservative FreeEQ 20MG BASE/2ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Methotrexate Sodium | DiscontinuedReference drug |
| Oct 15, 2026 | Supplement 144Labeling · Standard review | Approved | |
| May 28, 2025 | Supplement 142Labeling · Standard review | Approved | |
| Nov 27, 2023 | Supplement 136Manufacturing | Approved | |
| Nov 16, 2023 | Supplement 138Labeling · Standard review | Approved | |
| May 2, 2022 | Supplement 135Labeling · Standard review | Approved | |
| Mar 29, 2021 | Supplement 131Efficacy (new indication or use) · Standard review | Approved | |
| May 7, 2018 | Supplement 125Labeling · Standard review | Approved | |
| Mar 15, 2018 | Supplement 126Labeling | Approved | |
| Feb 3, 2016 | Supplement 124Manufacturing · Standard review | Approved | None posted |
| Nov 20, 2015 | Supplement 122Labeling · Standard review | Approved | |
| Aug 14, 2015 | Supplement 121Manufacturing · Standard review | Approved | None posted |
| Nov 1, 2011 | Supplement 117Labeling | Approved | |
| Apr 13, 2005 | Supplement 108Manufacturing · Standard review | Approved | |
| Dec 15, 2004 | Supplement 107Manufacturing · Standard review | Approved | |
| Jan 27, 2004 | Supplement 106Labeling · Standard review | Approved | |
| Jul 29, 2003 | Supplement 105Labeling · Standard review | Approved | |
| Jan 3, 2003 | Supplement 104Labeling · Standard review | Approved | |
| Feb 20, 2002 | Supplement 103Labeling · Standard review | Approved | |
| Feb 20, 2002 | Supplement 102Labeling · Standard review | Approved | |
| May 8, 2001 | Supplement 100Labeling · Standard review | Approved | None posted |
| Nov 8, 2000 | Supplement 96Labeling · Standard review | Approved | None posted |
| Oct 29, 1999 | Supplement 99Labeling · Standard review | Approved | None posted |
| Feb 12, 1999 | Supplement 98Manufacturing · Standard review | Approved | None posted |
| Jun 22, 1998 | Supplement 97Manufacturing · Standard review | Approved | None posted |
| May 20, 1997 | Supplement 95Labeling · Standard review | Approved | None posted |
| Apr 25, 1995 | Supplement 94Manufacturing · Standard review | Approved | None posted |
| Jan 23, 1992 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1991 | Supplement 86Manufacturing · Standard review | Approved | None posted |
| Feb 20, 1991 | Supplement 83Manufacturing · Standard review | Approved | None posted |
| Oct 24, 1990 | Supplement 85Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1990 | Supplement 76Labeling | Approved | None posted |
| Mar 1, 1989 | Supplement 81Manufacturing · Standard review | Approved | None posted |
| Apr 21, 1988 | Supplement 79Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1988 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1988 | Supplement 77Efficacy (new indication or use) | Approved | None posted |
| Aug 18, 1987 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Mar 19, 1987 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1986 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1986 | Supplement 73Labeling | Approved | None posted |
| Sep 16, 1986 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1983 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1983 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1982 | Supplement 62Labeling | Approved | None posted |
| Mar 31, 1982 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Mar 31, 1982 | Supplement 57Labeling | Approved | None posted |
| Dec 7, 1981 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| May 11, 1981 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1980 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1980 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Feb 29, 1980 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Oct 15, 1979 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1979 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Jan 2, 1979 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1978 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Aug 22, 1978 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1978 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1977 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jul 14, 1977 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1977 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Mar 18, 1977 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Sep 14, 1976 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Sep 14, 1976 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Sep 7, 1976 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Sep 7, 1976 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Sep 7, 1976 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Aug 3, 1976 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jun 29, 1976 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jun 29, 1976 | Supplement 26Labeling | Approved | None posted |
| Jun 29, 1976 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Dec 5, 1975 | Supplement 24Labeling | Approved | None posted |
| Nov 3, 1975 | Supplement 23Labeling | Approved | None posted |
| Nov 3, 1975 | Supplement 22Labeling | Approved | None posted |
| Jul 22, 1975 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Aug 10, 1959 | Original applicationNew active ingredient · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
