Orange Book product · Brand (NDA)
METHOTREXATE SODIUM PRESERVATIVE FREE
METHOTREXATE SODIUM
At a glance
Apr 13, 2005
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 13, 2005
21 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
METHOTREXATE SODIUM
Strength
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 011719
Product number
012
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2017XATMEPBrand (NDA)
NDA 208400 · AZURITY
- 2026METHOTREXATE SODIUMGeneric (ANDA)
ANDA 219865 · HETERO LABS LTD VI
- 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.
