Drugs@FDA: FDA-Approved Drugs

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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 None 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
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 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 201530 MYLAN LABS LTD
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
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 090029 SANDOZ 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 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 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
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 090039 SANDOZ INC
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 089340 WEST-WARD PHARMS INT

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 MYLAN LABS LTD
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
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 090039 SANDOZ INC
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 089343 WEST-WARD PHARMS INT

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