OREXO US INC FDA Approval NDA 204242

NDA 204242

OREXO US INC

FDA Drug Application

Application #204242

Documents

Letter2013-07-08
Letter2014-12-12
Label2015-02-03
Label2015-06-10
Letter2013-09-09
Letter2015-08-11
Letter2015-02-17
Letter2015-06-10
Letter2016-07-12
Label2013-07-05
Label2015-08-11
Review2014-06-27
Other2013-07-23
Letter2016-10-06
Label2016-10-07
Letter2016-12-21
Label2016-12-21
Letter2017-05-25
Label2017-09-11
Letter2017-09-11
Label2018-02-01
Letter2018-02-02
Letter2018-11-06
Letter2019-10-09
Label2019-10-09
Medication Guide2019-10-09
Letter2021-03-08
Label2021-03-08
Medication Guide2021-03-08
Letter2022-05-04
Letter2022-06-21
Letter2022-06-21
Label2022-06-21
Label2022-06-21
Medication Guide2022-06-21
Letter2022-12-29

Application Sponsors

NDA 204242OREXO US INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET;SUBLINGUALEQ 1.4MG BASE;EQ 0.36MG BASE1ZUBSOLVBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
002TABLET;SUBLINGUALEQ 5.7MG BASE;EQ 1.4MG BASE1ZUBSOLVBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
003TABLET;SUBLINGUALEQ 8.6MG BASE;EQ 2.1MG BASE1ZUBSOLVBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
004TABLET;SUBLINGUALEQ 11.4MG BASE;EQ 2.9MG BASE1ZUBSOLVBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
005TABLET;SUBLINGUALEQ 2.9MG BASE;EQ 0.71MG BASE1ZUBSOLVBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
006TABLET;SUBLINGUALEQ 0.7MG BASE;EQ 0.18MG BASE1ZUBSOLVBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2013-07-03STANDARD
REMS; REMSSUPPL2AP2013-09-04N/A
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2014-12-11STANDARD
EFFICACY; EfficacySUPPL4AP2015-08-10STANDARD
REMS; REMSSUPPL5AP2015-02-12N/A
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2015-06-04STANDARD
EFFICACY; EfficacySUPPL7AP2016-10-04STANDARD
REMS; REMSSUPPL8AP2016-07-07N/A
LABELING; LabelingSUPPL9AP2016-12-16STANDARD
LABELING; LabelingSUPPL11AP2017-09-08STANDARD
REMS; REMSSUPPL12AP2017-05-23N/A
LABELING; LabelingSUPPL14AP2018-02-01STANDARD
REMS; REMSSUPPL15AP2018-10-31N/A
LABELING; LabelingSUPPL17AP2019-10-07STANDARD
LABELING; LabelingSUPPL19AP2021-03-04STANDARD
LABELING; LabelingSUPPL21AP2022-06-17STANDARD
REMS; REMSSUPPL22AP2022-05-03N/A
LABELING; LabelingSUPPL23AP2022-06-17STANDARD
REMS; REMSSUPPL24AP2022-12-16N/A

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL3Null0
SUPPL4Null6
SUPPL5Null6
SUPPL6Null0
SUPPL7Null15
SUPPL8Null6
SUPPL9Null7
SUPPL11Null7
SUPPL12Null7
SUPPL14Null7
SUPPL15Null7
SUPPL17Null7
SUPPL19Null7
SUPPL21Null6
SUPPL22Null15
SUPPL23Null7
SUPPL24Null6

CDER Filings

OREXO US INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204242
            [companyName] => OREXO US INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/204242s017lbl.pdf#page=18"]
            [products] => [{"drugName":"ZUBSOLV","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 1.4MG BASE;EQ 0.36MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZUBSOLV","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 5.7MG BASE;EQ 1.4MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZUBSOLV","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 8.6MG BASE;EQ 2.1MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZUBSOLV","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 11.4MG BASE;EQ 2.9MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ZUBSOLV","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 2.9MG BASE;EQ 0.71MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZUBSOLV","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 0.7MG BASE;EQ 0.18MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204242s017lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204242s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204242s014lbl.pdf\"}]","notes":""},{"actionDate":"09\/08\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204242s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204242s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204242s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/04\/2016","submission":"SUPPL-7","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204242s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2015","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204242s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/04\/2015","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204242s006lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/11\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204242s003lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"07\/03\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204242s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/03\/2013","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\\\/2013\\\/204242s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204242Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204242Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204242s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204242Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"10\/31\/2018","submission":"SUPPL-15","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204242Orig1s015ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/01\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204242s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204242Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"05\/23\/2017","submission":"SUPPL-12","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204242Orig1s012ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/08\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204242s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204242Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"12\/16\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204242s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204242Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"07\/07\/2016","submission":"SUPPL-8","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204242Orig1s008ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/04\/2016","submission":"SUPPL-7","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204242s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204242Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"06\/04\/2015","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204242s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204242Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"02\/12\/2015","submission":"SUPPL-5","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204242Orig1s005ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"08\/10\/2015","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204242s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204242Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"12\/11\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204242s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204242Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"09\/04\/2013","submission":"SUPPL-2","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204242Orig1s002ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"01\/14\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-07
        )

)
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