FDA NDA · NDA011719
METHOTREXATE
Sponsor: HOSPIRA
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APPLICATION
NDA011719
TYPE
NDA
ORIGINAL APPROVAL
1959-08-10
LATEST ACTION
2026-10-15
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRATHECAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
METHOTREXATE PRESERVATIVE FREE · ReferenceDiscontinued
METHOTREXATE SODIUM EQ 20MG BASE/2ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION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 · ReferenceDiscontinued
METHOTREXATE SODIUM EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
METHOTREXATE SODIUM PRESERVATIVE FREE · ReferencePrescription
METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
METHOTREXATE SODIUM · ReferenceDiscontinued
METHOTREXATE SODIUM EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
METHOTREXATE SODIUM · ReferencePrescription
METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
METHOTREXATE SODIUM PRESERVATIVE FREE · ReferenceDiscontinued
METHOTREXATE SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
METHOTREXATE LPF · ReferenceDiscontinued
METHOTREXATE SODIUM EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
METHOTREXATE PRESERVATIVE FREE · ReferenceDiscontinued
METHOTREXATE SODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION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 · ReferenceDiscontinued
METHOTREXATE SODIUM EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
METHOTREXATE PRESERVATIVE FREE · ReferenceDiscontinued
METHOTREXATE SODIUM EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION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 · ReferenceDiscontinued
METHOTREXATE SODIUM EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
METHOTREXATE SODIUM · ReferenceDiscontinued
METHOTREXATE SODIUM EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2016-02-03Manufacturing (CMC) · Supplement 124 · standardAP
2015-08-14Manufacturing (CMC) · Supplement 121 · standardAP
2001-05-08Labeling · Supplement 100 · standardAP
2000-11-08Labeling · Supplement 96 · standardAP
1999-10-29Labeling · Supplement 99 · standardAP
1999-02-12Manufacturing (CMC) · Supplement 98 · standardAP
1998-06-22Manufacturing (CMC) · Supplement 97 · standardAP
1997-05-20Labeling · Supplement 95 · standardAP
1995-04-25Manufacturing (CMC) · Supplement 94 · standardAP
1992-01-23Manufacturing (CMC) · Supplement 89 · standardAP
1991-11-05Manufacturing (CMC) · Supplement 86 · standardAP
1991-02-20Manufacturing (CMC) · Supplement 83 · standardAP
1990-10-24Manufacturing (CMC) · Supplement 85 · standardAP
1990-01-18Labeling · Supplement 76AP
1989-03-01Manufacturing (CMC) · Supplement 81 · standardAP
1988-04-21Manufacturing (CMC) · Supplement 79 · standardAP
1988-04-07Efficacy · Supplement 77AP
1988-04-07Manufacturing (CMC) · Supplement 78 · standardAP
1987-08-18Manufacturing (CMC) · Supplement 74 · standardAP
1987-03-19Manufacturing (CMC) · Supplement 70 · standardAP
1986-12-08Manufacturing (CMC) · Supplement 75 · standardAP
1986-09-16Labeling · Supplement 73AP
1986-09-16Manufacturing (CMC) · Supplement 71 · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →