Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 15MG | 1 | RINVOQ | UPADACITINIB |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 30MG | 1 | RINVOQ | UPADACITINIB |
| 003 | TABLET, EXTENDED RELEASE;ORAL | 45MG | 1 | RINVOQ | UPADACITINIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2019-08-16 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2021-12-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2022-04-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2022-01-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-12-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2022-03-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-12-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2022-10-21 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 10 | Null | 6 |
CDER Filings
ABBVIE INC
cder:Array
(
[0] => Array
(
[ApplNo] => 211675
[companyName] => ABBVIE INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/211675s000lbl.pdf#page=28"]
[products] => [{"drugName":"RINVOQ","activeIngredients":"UPADACITINIB","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/10\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211675s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211675s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211675s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/16\/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\\\/211675s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211675Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211675Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"07\/10\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211675s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211675Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-07-10
)
)