Documents
Application Sponsors
| NDA 212018 | JANSSEN BIOTECH | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 3MG | 1 | BALVERSA | ERDAFITINIB |
| 002 | TABLET;ORAL | 4MG | 1 | BALVERSA | ERDAFITINIB |
| 003 | TABLET;ORAL | 5MG | 1 | BALVERSA | ERDAFITINIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2019-04-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2022-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2022-04-28 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2023-01-11 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 6 |
CDER Filings
JANSSEN BIOTECH
cder:Array
(
[0] => Array
(
[ApplNo] => 212018
[companyName] => JANSSEN BIOTECH
[docInserts] => ["",""]
[products] => [{"drugName":"BALVERSA","activeIngredients":"ERDAFITINIB","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"BALVERSA","activeIngredients":"ERDAFITINIB","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"BALVERSA","activeIngredients":"ERDAFITINIB","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/02\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212018s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212018s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/12\/2019","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\\\/2019\\\/212018s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212018Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212018Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"04\/02\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212018s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212018Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-04-02
)
)