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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090029
Company: SANDOZ

Products on ANDA 090029

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090029

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2009	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
10/25/2021	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/25/2021	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/30/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090029

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	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

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