NDA 209830

ALKERMES INC

FDA Drug Application

Application #209830

Documents

• Label: 2018-07-06
• Review: 2019-06-13
• Letter: 2020-08-28
• Label: 2020-09-04
• Medication Guide: 2020-09-04
• Letter: 2021-03-31

Application Sponsors

NDA 209830

ALKERMES INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

675MG/2.4ML

1

ARISTADA INITIO KIT

ARIPIPRAZOLE LAUROXIL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-06-29	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-08-27	STANDARD
LABELING; Labeling	SUPPL	9	TA	2020-10-14	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	5	Null	7
SUPPL	9	Null	4

CDER Filings

ALKERMES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209830
            [companyName] => ALKERMES INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/207533s017,209830s005lbl.pdf#page=72"]
            [products] => [{"drugName":"ARISTADA INITIO KIT","activeIngredients":"ARIPIPRAZOLE LAUROXIL","strength":"675MG\/2.4ML","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/27\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207533s017,209830s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209830lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/29\/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\\\/209830lbl.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/209830Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/27\/2020","submission":"SUPPL-5","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\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207533Orig1s017,%20209830Orig1s005ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-08-27
        )

)