Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 75MG/0.83ML | 0 | SKYRIZI | RISANKIZUMAB-RZAA |
| 002 | INJECTABLE;INJECTION | 150MG/ML | 0 | SKYRIZI | RISANKIZUMAB-RZAA |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2019-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-03-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2021-04-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2021-04-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2022-01-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2022-06-16 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2022-09-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 18 | Null | 15 |
CDER Filings
ABBVIE INC
cder:Array
(
[0] => Array
(
[ApplNo] => 761105
[companyName] => ABBVIE INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761105s005lbl.pdf#page=13"]
[products] => [{"drugName":"SKYRIZI","activeIngredients":"RISANKIZUMAB-RZAA","strength":"75MG\/0.83ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"03\/20\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761105s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761105s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761105s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761105s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761105Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"03\/20\/2020","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761105s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761105Orig1s005ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-03-20
)
)