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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217552
Company: ALEMBIC

Products on ANDA 217552

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217552

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/27/2026	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 217552

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	217552	ALEMBIC
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	216453	ELITE LABS INC
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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