Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201529
Company: EUGIA PHARMA SPECLTS

Products on ANDA 201529

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
METHOTREXATE SODIUM PRESERVATIVE FREE	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 201529

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/19/2021	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/19/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/05/2015	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
10/05/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.