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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040768
Company: ACCORD HLTHCARE

Products on ANDA 040768

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040768

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2007	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
08/16/2023	SUPPL-12	Labeling-Container/Carton Labels		Label is not available on this site.
06/07/2021	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
03/16/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040768

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	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
METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090039	SANDOZ

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