Documents
Application Sponsors
| NDA 210951 | JANSSEN BIOTECH | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 60MG | 1 | ERLEADA | APALUTAMIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-02-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-07-10 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-09-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2020-11-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-07-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2021-09-07 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2022-04-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2022-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-11-08 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 6 |
CDER Filings
JANSSEN BIOTECH
cder:Array
(
[0] => Array
(
[ApplNo] => 210951
[companyName] => JANSSEN BIOTECH
[docInserts] => ["",""]
[products] => [{"drugName":"ERLEADA","activeIngredients":"APALUTAMIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/10\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210951s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/17\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210951s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210951s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"02\/14\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210951s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210951Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/Erleada_210951_toc.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"09\/01\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/10\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210951s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210951Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"09\/17\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210951s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210951Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-09-01
)
)