ALKERMES INC FDA Approval NDA 207533

NDA 207533

ALKERMES INC

FDA Drug Application

Application #207533

Documents

Letter2015-10-13
Label2015-10-13
Review2015-10-28
Summary Review2015-10-16
Label2016-08-22
Letter2016-08-18
Label2017-02-24
Letter2017-03-02
Label2017-06-06
Medication Guide2017-06-06
Letter2017-06-07
Letter2018-01-30
Label2018-12-03
Letter2020-08-28
Label2020-09-04
Medication Guide2020-09-04
Letter2021-03-31

Application Sponsors

NDA 207533ALKERMES INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR441MG/1.6ML (275.63MG/ML)1ARISTADAARIPIPRAZOLE LAUROXIL
002SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR662MG/2.4ML (275.83MG/ML)1ARISTADAARIPIPRAZOLE LAUROXIL
003SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR882MG/3.2ML (275.63MG/ML)1ARISTADAARIPIPRAZOLE LAUROXIL
004SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR1064MG/3.9ML (272.82MG/ML)1ARISTADAARIPIPRAZOLE LAUROXIL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2015-10-05STANDARD
LABELING; LabelingSUPPL3AP2016-08-18901 REQUIRED
EFFICACY; EfficacySUPPL4AP2017-06-05STANDARD
LABELING; LabelingSUPPL6AP2017-02-23901 REQUIRED
LABELING; LabelingSUPPL9AP2018-01-25STANDARD
LABELING; LabelingSUPPL13AP2018-11-30STANDARD
LABELING; LabelingSUPPL17AP2020-08-27STANDARD
LABELING; LabelingSUPPL21TA2020-10-14STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null7
SUPPL4Null15
SUPPL6Null7
SUPPL9Null6
SUPPL13Null7
SUPPL17Null15
SUPPL21Null15

CDER Filings

ALKERMES INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207533
            [companyName] => ALKERMES INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/207533s017,209830s005lbl.pdf#page=36"]
            [products] => [{"drugName":"ARISTADA","activeIngredients":"ARIPIPRAZOLE LAUROXIL","strength":"441MG\/1.6ML (275.63MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ARISTADA","activeIngredients":"ARIPIPRAZOLE LAUROXIL","strength":"662MG\/2.4ML (275.83MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ARISTADA","activeIngredients":"ARIPIPRAZOLE LAUROXIL","strength":"882MG\/3.2ML (275.63MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ARISTADA","activeIngredients":"ARIPIPRAZOLE LAUROXIL","strength":"1064MG\/3.9ML (272.82MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/27\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207533s017,209830s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207533s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2017","submission":"SUPPL-4","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207533s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207533s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/18\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207533s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207533s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/05\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207533s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207533Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207533Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207533Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/27\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207533s017,209830s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/30\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207533s013lbl.pdf\"}]","notes":">"},{"actionDate":"01\/25\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207533Orig1s009ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/23\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207533s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207533Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"06\/05\/2017","submission":"SUPPL-4","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207533s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207533Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"08\/18\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207533s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207533Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"03\/24\/2016","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-27
        )

)
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