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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040054
Company: HIKMA

Products on ANDA 040054

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040054

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/01/1994	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
10/29/2020	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040054Orig1s015, s016, s017ltr.pdf
10/29/2020	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040054Orig1s015, s016, s017ltr.pdf
10/29/2020	SUPPL-15	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040054Orig1s015, s016, s017ltr.pdf
11/26/2007	SUPPL-5	Labeling		Label is not available on this site.
09/13/2006	SUPPL-4	Labeling		Label is not available on this site.
10/30/2001	SUPPL-3	Labeling		Label is not available on this site.
05/07/1998	SUPPL-2	Labeling		Label is not available on this site.
11/10/1994	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 040054

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2020	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf
10/29/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf
10/29/2020	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf
10/29/2020	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf

Therapeutic Equivalents for ANDA 040054

METHOTREXATE SODIUM

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	213343	ACCORD HLTHCARE
METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	210040	AMNEAL PHARMS
METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	081099	BARR
METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	213362	DAITO
METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	210454	EUGIA PHARMA
METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	040054	HIKMA
METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	081235	MYLAN
METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	201749	SUN PHARM
METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	207812	ZYDUS PHARMS

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