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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040263
Company: FRESENIUS KABI USA

Products on ANDA 040263

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE;INJECTION	Prescription	AP	No	Yes
METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040263

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40263_Methotrexate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40263ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040263_methotrexate_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2023	SUPPL-19	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/27/2021	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/27/2021	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/07/2017	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
03/29/2012	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/02/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 040263

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40263_Methotrexate_Prntlbl.pdf

Therapeutic Equivalents for ANDA 040263

METHOTREXATE SODIUM

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	089340	HIKMA
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

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