Documents
Application Sponsors
| NDA 208042 | TEVA PHARMS USA | |
Marketing Status
Application Products
| 001 | FILM;SUBLINGUAL | EQ 16MG BASE;EQ 4MG BASE | 1 | CASSIPA | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2018-09-07 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2022-06-17 | STANDARD |
| REMS; REMS | SUPPL | 6 | AP | 2022-05-03 | N/A |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-06-17 | STANDARD |
| REMS; REMS | SUPPL | 8 | AP | 2022-12-16 | N/A |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 31 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 6 |
CDER Filings
TEVA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 208042
[companyName] => TEVA PHARMS USA
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/208042s001lbl.pdf#page=27"]
[products] => [{"drugName":"CASSIPA","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 16MG BASE;EQ 4MG BASE","dosageForm":"FILM;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208042s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208042s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208042s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208042s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208042Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208042Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208042s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208042Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-10-07
)
)