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Drugs@FDA: FDA-Approved Drugs

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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
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
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

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