GENUS FDA Approval NDA 204768

NDA 204768

GENUS

FDA Drug Application

Application #204768

Documents

Letter2014-02-26
Letter2016-05-10
Letter2016-05-10
Label2014-02-25
Label2016-05-11
Label2016-05-11
Review2014-08-07
Medication Guide2016-05-18
Summary Review2014-08-07
Label2019-03-26
Medication Guide2019-03-26
Letter2019-03-28
Letter2021-04-30
Label2021-05-03
Medication Guide2021-05-03

Application Sponsors

NDA 204768GENUS

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL20MG1TIVORBEXINDOMETHACIN
002CAPSULE;ORAL40MG1TIVORBEXINDOMETHACIN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2014-02-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2015-07-15STANDARD
LABELING; LabelingSUPPL3AP2016-05-09STANDARD
LABELING; LabelingSUPPL4AP2016-05-09STANDARD
LABELING; LabelingSUPPL6AP2019-03-26STANDARD
LABELING; LabelingSUPPL8AP2021-04-28STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null0
SUPPL3Null15
SUPPL4Null15
SUPPL6Null6
SUPPL8Null15

CDER Filings

GENUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204768
            [companyName] => GENUS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/204768s008lbl.pdf#page=25"]
            [products] => [{"drugName":"TIVORBEX","activeIngredients":"INDOMETHACIN","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TIVORBEX","activeIngredients":"INDOMETHACIN","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/28\/2021","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204768s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2021","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204768s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204768s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204768s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204768s003s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204768s003s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204768s003s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204768s003s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204768s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/24\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204768s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204768Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204768Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204768Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/28\/2021","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204768s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/204768Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"03\/26\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204768s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204768Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"05\/09\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204768s003s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204768Orig1s003,s004ltr.pdf\"}]","notes":">"},{"actionDate":"05\/09\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204768s003s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204768Orig1s003,s004ltr.pdf\"}]","notes":">"},{"actionDate":"07\/15\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-04-28
        )

)
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