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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208400
Company: AZURITY

Products on NDA 208400

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XATMEP	METHOTREXATE SODIUM	EQ 2.5MG BASE/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208400

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2017	ORIG-2	Approval	Efficacy	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208400s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208400Orig1s000,208400Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208400Orig1Orig2s000TOC.html
04/25/2017	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208400s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208400Orig1s000,208400Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208400Orig1Orig2s000TOC.html

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-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208400s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208400Orig1s005ltr.pdf
03/15/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208004s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208400Orig1s002ltr.pdf

Labels for NDA 208400

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/27/2026	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208400s005lbl.pdf
05/27/2026	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208400s005lbl.pdf
03/15/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208004s002lbl.pdf
04/25/2017	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208400s000lbl.pdf
04/25/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208400s000lbl.pdf

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