NDA 210655

INDIVIOR INC

FDA Drug Application

Application #210655

Documents

• Letter: 2018-08-03
• Label: 2018-08-07
• Review: 2018-07-27
• Label: 2020-02-06
• Letter: 2020-02-06
• Label: 2022-11-03
• Letter: 2022-12-16
• Label: 2022-12-22

Application Sponsors

NDA 210655

INDIVIOR INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	90MG	1	PERSERIS KIT	RISPERIDONE
002	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	120MG	1	PERSERIS KIT	RISPERIDONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2018-07-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-02-05	901 REQUIRED
EFFICACY; Efficacy	SUPPL	10	AP	2022-12-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2022-08-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	7
SUPPL	10	Null	6

CDER Filings

INDIVIOR INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210655
            [companyName] => INDIVIOR INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERSERIS KIT","activeIngredients":"RISPERIDONE","strength":"90MG","dosageForm":"FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"PERSERIS KIT","activeIngredients":"RISPERIDONE","strength":"120MG","dosageForm":"FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/05\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210655s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210655s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/27\/2018","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\\\/2018\\\/210655s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210655Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210655Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/05\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210655s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210655Orig1s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-02-05
        )

)