Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 150MG BASE | 1 | ORILISSA | ELAGOLIX SODIUM |
| 002 | TABLET;ORAL | EQ 200MG BASE | 1 | ORILISSA | ELAGOLIX SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-07-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-08-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2021-02-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2021-02-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2021-02-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 6 |
CDER Filings
ABBVIE INC
cder:Array
(
[0] => Array
(
[ApplNo] => 210450
[companyName] => ABBVIE INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/210450s002lbl.pdf#page=27"]
[products] => [{"drugName":"ORILISSA","activeIngredients":"ELAGOLIX SODIUM","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ORILISSA","activeIngredients":"ELAGOLIX SODIUM","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/28\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210450s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210450s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/23\/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\\\/210450s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210450Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210450Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"08\/28\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210450s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210450Orig1s002ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-08-28
)
)