NDA 215859

JANSSEN PHARMS

FDA Drug Application

Application #215859

Documents

• Label: 2021-12-20
• Medication Guide: 2021-12-20
• Letter: 2021-12-22
• Review: 2022-05-06

Application Sponsors

NDA 215859

JANSSEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

1MG/ML

2

XARELTO

RIVAROXABAN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2021-12-20

PRIORITY

Submissions Property Types

ORIG

1

Null

6

TE Codes

001

Prescription

TBD

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215859
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/215859s000lbl.pdf#page=77"]
            [products] => [{"drugName":"XARELTO","activeIngredients":"RIVAROXABAN","strength":"1MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/20\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215859s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215859s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-20
        )

)