Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203388
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERIVEDGE VISMODEGIB 150MG CAPSULE;ORAL Prescription None Yes Yes
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
03/26/2019 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-Package Insert, Labeling-Package Insert, Labeling-Medication Guide 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-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
05/21/2015 SUPPL-5 Labeling-Medication Guide 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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