Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;SUBLINGUAL | EQ 2MG BASE;EQ 0.5MG BASE | 0 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
| 002 | TABLET;SUBLINGUAL | EQ 8MG BASE;EQ 2MG BASE | 0 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2014-06-27 | |
| REMS; REMS | SUPPL | 2 | AP | 2015-02-12 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-02-04 | STANDARD |
| REMS; REMS | SUPPL | 4 | AP | 2016-07-07 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-12-16 | STANDARD |
| REMS; REMS | SUPPL | 7 | AP | 2017-05-23 | |
| LABELING; Labeling | SUPPL | 10 | AP | 2018-02-01 | STANDARD |
| REMS; REMS | SUPPL | 11 | AP | 2018-10-31 | |
| LABELING; Labeling | SUPPL | 14 | AP | 2019-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2022-06-14 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2022-06-17 | STANDARD |
| REMS; REMS | SUPPL | 24 | AP | 2022-05-03 | |
| LABELING; Labeling | SUPPL | 25 | AP | 2022-06-17 | STANDARD |
| REMS; REMS | SUPPL | 27 | AP | 2022-12-16 | |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 27 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
HIKMA
cder:Array
(
[0] => Array
(
[ApplNo] => 203326
[companyName] => HIKMA
[docInserts] => ["",""]
[products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 2MG BASE;EQ 0.5MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 8MG BASE;EQ 2MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/31\/2018","submission":"SUPPL-11","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/01\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/23\/2017","submission":"SUPPL-7","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/07\/2016","submission":"SUPPL-4","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/04\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/12\/2015","submission":"SUPPL-2","supplementCategories":"REMS-Proposal","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-07
)
)