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Abbreviated New Drug Application (ANDA): 040843
Company: PHARMACHEMIE BV

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription AP No No
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription AP No No
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription AP No No
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription AP No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/08/2010 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/14/2026 SUPPL-14 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
01/14/2026 SUPPL-13 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
08/02/2021 SUPPL-11 Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
08/02/2021 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
02/24/2017 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
03/30/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

METHOTREXATE SODIUM PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 220225 ALEMBIC
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040716 ACCORD HLTHCARE
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription Yes AP 011719 HOSPIRA
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040843 PHARMACHEMIE BV
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 203407 SAGENT PHARMS INC

INJECTABLE;INJECTION; EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 220225 ALEMBIC
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040263 FRESENIUS KABI USA
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription Yes AP 011719 HOSPIRA
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040767 ACCORD HLTHCARE
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 201529 EUGIA PHARMA SPECLTS
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 089340 HIKMA
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040843 PHARMACHEMIE BV
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 203407 SAGENT PHARMS INC

INJECTABLE;INJECTION; EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 089341 HIKMA
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 201529 EUGIA PHARMA SPECLTS
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040843 PHARMACHEMIE BV

INJECTABLE;INJECTION; EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040768 ACCORD HLTHCARE
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 201529 EUGIA PHARMA SPECLTS
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 089343 HIKMA
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 040843 PHARMACHEMIE BV
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 203407 SAGENT PHARMS INC
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