Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090039
Company: CAPLIN ONE LABS

Products on ANDA 090039

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 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090039

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2009	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
01/31/2025	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
01/31/2025	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
10/25/2021	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/25/2021	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
03/30/2012	SUPPL-3	Labeling-Package Insert		Label is not available on this site.