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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220225
Company: ALEMBIC

Products on ANDA 220225

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	No
METHOTREXATE SODIUM	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 220225

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220225

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	220225	ALEMBIC
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	201529	EUGIA PHARMA SPECLTS
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

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	METHOTREXATE SODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	220225	ALEMBIC
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

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