Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201529
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Discontinued None No No
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Discontinued None No No
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 200MG BASE/8ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Discontinued 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
03/29/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/05/2015 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

10/05/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

METHOTREXATE SODIUM PRESERVATIVE FREE

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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