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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202429
Company: HOFFMANN LA ROCHE

Medication Guide

Summary Review

Products on NDA 202429

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZELBORAF	VEMURAFENIB	240MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202429

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2011	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202429Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202429s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/18/2020	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202429s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202429Orig1s019ltr.pdf
11/06/2017	SUPPL-16	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202429Orig1s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/202429Orig1s016TOC.html
09/13/2017	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202429Orig1s015ltr.pdf
09/13/2017	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202429Orig1s014ltr.pdf
04/17/2017	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202429Orig1s012ltr.pdf
05/09/2016	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202429Orig1s010ltr.pdf
08/31/2016	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202429Orig1s009ltr.pdf
08/11/2015	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202429s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202429Orig1s008ltr.pdf
09/23/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/25/2014	SUPPL-6	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s006ltr.pdf
02/06/2014	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s005ltr.pdf
03/19/2014	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s004ltr.pdf
07/03/2013	SUPPL-3	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202429Orig1s002,s003ltr.pdf
07/03/2013	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202429Orig1s002,s003ltr.pdf

Labels for NDA 202429

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/18/2020	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202429s019lbl.pdf
11/06/2017	SUPPL-16	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s016lbl.pdf
04/17/2017	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s012lbl.pdf
08/31/2016	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s009lbl.pdf
05/09/2016	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s010lbl.pdf
08/11/2015	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202429s008lbl.pdf
11/25/2014	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s006lbl.pdf
03/19/2014	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s004lbl.pdf
02/06/2014	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s005lbl.pdf
07/03/2013	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf
07/03/2013	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf
08/17/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429s000lbl.pdf

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