Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 219293
Company: AZURITY

• Medication Guide

Products on NDA 219293

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DANZITEN	NILOTINIB TARTRATE	EQ 71MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes
DANZITEN	NILOTINIB TARTRATE	EQ 95MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 219293

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219293s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/219293Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219293Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2025	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219293Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219293Orig1s005ltr.pdf

Labels for NDA 219293

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2025	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219293Orig1s005lbl.pdf
11/07/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219293s000lbl.pdf