FDA.reportPublic FDA data

Application 202379

Type
NDA
Sponsor
JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYTIGAABIRATERONE ACETATETABLET;ORAL250MGYesNo
002ZYTIGAABIRATERONE ACETATETABLET;ORAL500MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-155Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDA AUTHORIZED GENERICCurrent
57894-155Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDA AUTHORIZED GENERICCurrent
57894-155Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDA AUTHORIZED GENERICCurrent
57894-155Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDA AUTHORIZED GENERICCurrent
57894-155Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDA AUTHORIZED GENERICCurrent
57894-155Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDA AUTHORIZED GENERICCurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-199Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-199Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-199Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68458SUPPL2021-08-25
68455SUPPL2021-08-25
64851SUPPL2020-10-06
64850SUPPL2020-10-06
64826SUPPL2020-10-05
64825SUPPL2020-10-05
58979SUPPL2019-06-05
58978SUPPL2019-06-05
58973SUPPL2019-06-05
58972SUPPL2019-06-05
55746SUPPL2018-10-01
55617SUPPL2018-09-26
54304SUPPL2018-05-22
52563SUPPL2018-02-12
52522SUPPL2018-02-08
45794SUPPL2016-11-02
40178SUPPL2016-05-20
32253SUPPL2016-05-19
19342SUPPL2015-12-15
32252SUPPL2015-12-11
19341SUPPL2015-05-27
10041SUPPL2015-05-22
32251SUPPL2015-03-24
19340SUPPL2015-03-24
40177SUPPL2015-01-29
10040SUPPL2015-01-26
10039SUPPL2014-05-19
19339SUPPL2014-05-15
22888SUPPL2014-01-16
19338SUPPL2013-09-17
10038SUPPL2013-09-13
19337SUPPL2012-12-14
10037SUPPL2012-12-12
32250SUPPL2012-09-20
40176SUPPL2012-09-17
40175SUPPL2012-07-13
10036SUPPL2012-07-09
44856ORIG2011-05-27
43400ORIG2011-05-27
32249ORIG2011-05-03
19336ORIG2011-04-28