Drugs@FDA: FDA-Approved Drugs

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New Drug Application:
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Products on 200171

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS

Approval Date(s) and History, Letters, Labels, Reviews for

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2012	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
02/06/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for 200171

METHOTREXATE PRESERVATIVE FREE

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