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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203388
Company: GENENTECH

Medication Guide

Products on NDA 203388

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERIVEDGE	VISMODEGIB	150MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203388

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/2012	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203388lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203388s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203388Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2023	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203388s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203388Orig1s017ltr.pdf
07/31/2020	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203388s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203388Orig1s016ltr.pdf
03/26/2019	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203388s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203388Orig1s014ltr.pdf
01/18/2019	SUPPL-12	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203388s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203388Orig1s012ltr.pdf
08/01/2017	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203388s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203388Orig1s011ltr.pdf
11/02/2016	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203388s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203388Orig1s010ltr.pdf
05/21/2015	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s007,s008ltr.pdf
05/21/2015	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s007,s008ltr.pdf
05/21/2015	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s007,s008ltr.pdf
05/21/2015	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s007,s008ltr.pdf
10/15/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/19/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/03/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/08/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203388

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2023	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203388s017lbl.pdf
07/31/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203388s016lbl.pdf
03/26/2019	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203388s014lbl.pdf
01/18/2019	SUPPL-12	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203388s012lbl.pdf
08/01/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203388s011lbl.pdf
11/02/2016	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203388s010lbl.pdf
11/02/2016	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203388s010lbl.pdf
05/21/2015	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf
05/21/2015	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf
05/21/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf
05/21/2015	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf
05/21/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf
05/21/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf
01/30/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203388lbl.pdf

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