FDA.reportPublic FDA data

Application 203085

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STIVARGAREGORAFENIBTABLET;ORAL40MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-171StivargaregorafenibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-171StivargaregorafenibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-171StivargaregorafenibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-171StivargaregorafenibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-171StivargaregorafenibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-171StivargaregorafenibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-171StivargaregorafenibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-171StivargaregorafenibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-171StivargaregorafenibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-171StivargaregorafenibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-171StivargaregorafenibBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84939SUPPL 2026-02-05
84922SUPPL 2026-02-05
84921SUPPL 2026-02-05
81375SUPPL 2025-02-26
81373SUPPL 2025-02-26
65704SUPPL2020-12-23
65703SUPPL2020-12-23
64682SUPPL2020-09-25
64002SUPPL2020-07-22
63995SUPPL2020-07-22
61895SUPPL2020-02-14
61889SUPPL2020-02-14
59617SUPPL2019-08-07
59558SUPPL2019-08-02
59534SUPPL2019-08-01
54669SUPPL2018-06-21
54632SUPPL2018-06-20
48215SUPPL2017-05-02
48129SUPPL2017-04-27
45173SUPPL2016-08-26
45058SUPPL2016-08-26
10153SUPPL2016-06-08
10152SUPPL2015-04-16
40256SUPPL2015-04-14
19417SUPPL2013-06-04
32368SUPPL2013-05-31
43419ORIG2012-10-26
24425ORIG2012-10-26
32367ORIG2012-09-27
19416ORIG2012-09-27