Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 100MG/0.5ML (100MG/0.5ML) | 1 | SUBLOCADE | BUPRENORPHINE |
| 002 | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 300MG/1.5ML (200MG/ML) | 1 | SUBLOCADE | BUPRENORPHINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2017-11-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-08-23 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2020-02-04 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2021-05-11 | STANDARD |
| REMS; REMS | SUPPL | 16 | AP | 2020-06-15 | N/A |
| LABELING; Labeling | SUPPL | 17 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2021-03-04 | STANDARD |
| REMS; REMS | SUPPL | 19 | AP | 2021-09-22 | N/A |
| LABELING; Labeling | SUPPL | 20 | AP | 2022-06-17 | STANDARD |
| REMS; REMS | SUPPL | 21 | AP | 2023-01-06 | N/A |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 12 | Orphan | 5 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 6 |
CDER Filings
INDIVIOR INC
cder:Array
(
[0] => Array
(
[ApplNo] => 209819
[companyName] => INDIVIOR INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/209819s012lbl.pdf#page=41"]
[products] => [{"drugName":"SUBLOCADE","activeIngredients":"BUPRENORPHINE","strength":"100MG\/0.5ML (100MG\/0.5ML)","dosageForm":"SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SUBLOCADE","activeIngredients":"BUPRENORPHINE","strength":"300MG\/1.5ML (200MG\/ML)","dosageForm":"SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"02\/04\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209819s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209819s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209819s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209819s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/30\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209819s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209819Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209819Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/summary_review\\\/2017\\\/209819Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"06\/15\/2020","submission":"SUPPL-16","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209819Orig1s016ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/04\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209819s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209819Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"10\/07\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209819s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209819Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"03\/05\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209819s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209819Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-06-15
)
)