FDA.reportPublic FDA data

Application 206192

Type
NDA
Sponsor
GENENTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COTELLICCOBIMETINIB FUMARATETABLET;ORALEQ 20MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-717CotellicCOBIMETINIBGenentech, Inc.NDACurrent
50242-717CotellicCOBIMETINIBGenentech, Inc.NDACurrent
50242-717CotellicCOBIMETINIBGenentech, Inc.NDACurrent
50242-717CotellicCOBIMETINIBGenentech, Inc.NDACurrent
50242-717CotellicCOBIMETINIBGenentech, Inc.NDACurrent
50242-717CotellicCOBIMETINIBGenentech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74424SUPPL 2023-06-01
74420SUPPL 2023-06-01
72503SUPPL2022-10-31
72495SUPPL2022-10-31
71666SUPPL2022-07-29
71664SUPPL2022-07-29
52128SUPPL2018-01-30
52086SUPPL2018-01-30
40528SUPPL2016-06-01
32785SUPPL2016-06-01
44938ORIG2015-12-08
23015ORIG2015-12-08
19708ORIG2015-11-10
10549ORIG2015-11-10