An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 217514
Company: NOVARTIS

Medication Guide

Products on NDA 217514

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAFINLAR	DABRAFENIB MESYLATE	EQ 10MG BASE	TABLET, FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes
TAFINLAR	DABRAFENIB MESYLATE	75MG	CAPSULE;ORAL	Prescription	None	No	No
TAFINLAR	DABRAFENIB MESYLATE	10MG	TABLET; ORAL SUSPENSION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217514

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2023	ORIG-1	Approval	New Combination and New Formulation or New Manufacturer	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217514s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217514Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217514Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2025	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202806s036,217514s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202806Orig1s036;217514Orig1s010ltr.pdf
04/07/2025	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202806s038,217514s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202806Orig1s038_217514Orig1s009ltr.pdf
03/19/2025	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202806s037,217514s008lbl.pdf
03/07/2025	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202806s033,217514s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202806Orig1s033,217514Orig1s006ltr.pdf
07/11/2024	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202806s031,217514s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202806Orig1s031;217514Orig1s004ltr.pdf
03/29/2024	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217514s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217514Orig1s003ltr.pdf
02/27/2024	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202806s029,217514s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202806Orig1s029; 217514Orig1s002ltr.pdf

Labels for NDA 217514

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/07/2025	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202806s038,217514s009lbl.pdf
03/19/2025	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202806s037,217514s008lbl.pdf
03/07/2025	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202806s033,217514s006lbl.pdf
01/30/2025	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202806s036,217514s010lbl.pdf
07/11/2024	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202806s031,217514s004lbl.pdf
03/29/2024	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217514s003lbl.pdf
02/27/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202806s029,217514s002lbl.pdf
03/16/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217514s000lbl.pdf

Top