Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 206192
Company: GENENTECH INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COTELLIC COBIMETINIB FUMARATE EQ 20MG BASE TABLET;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
11/10/2015 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/2015/206192s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206192Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206192Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206192Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/31/2016 SUPPL-1 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206192s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206192Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/31/2016 SUPPL-1 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206192s001lbl.pdf
05/31/2016 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206192s001lbl.pdf
11/10/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206192s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English