Orange Book product · Generic (ANDA)
METHOTREXATE SODIUM
METHOTREXATE SODIUM
At a glance
Apr 30, 2026
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 30, 2026
2 mo ago
Today
Pharmaceutical detail
Active ingredient
METHOTREXATE SODIUM
Strength
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 219865
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of METHOTREXATE SODIUM
- 2017XATMEPBrand (NDA)
NDA 208400 · AZURITY
- 1982METHOTREXATE LPFBrand (NDA)
NDA 011719 · HOSPIRA
- 2026METHOTREXATE SODIUMGeneric (ANDA)
ANDA 220225 · ALEMBIC
- 2024METHOTREXATE SODIUMGeneric (ANDA)
ANDA 217552 · ALEMBIC
- 2024METHOTREXATE SODIUMGeneric (ANDA)
ANDA 216453 · ELITE LABS INC
- 2023METHOTREXATE SODIUMGeneric (ANDA)
ANDA 213362 · DAITO
- 2021METHOTREXATE SODIUMGeneric (ANDA)
ANDA 209787 · LOTUS PHARM CO LTD
- 2020METHOTREXATE SODIUMGeneric (ANDA)
ANDA 210454 · EUGIA PHARMA
- 2020METHOTREXATE SODIUMGeneric (ANDA)
ANDA 213343 · ACCORD HLTHCARE
- 2018METHOTREXATE SODIUM PRESERVATIVE FREEGeneric (ANDA)
ANDA 203407 · SAGENT PHARMS INC
- 2017METHOTREXATE SODIUMGeneric (ANDA)
ANDA 210040 · AMNEAL PHARMS
- 2012METHOTREXATE SODIUM PRESERVATIVE FREEGeneric (ANDA)
ANDA 201529 · EUGIA PHARMA SPECLTS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
