INDIVIOR INC FDA Approval NDA 022410

Application #022410

Documents

Letter	2010-09-02
Letter	2014-04-29
Letter	2013-11-25
Letter	2014-04-29
Letter	2014-04-29
Letter	2015-09-24
Letter	2015-09-24
Label	2012-08-15
Label	2012-08-15
Label	2013-11-26
Label	2014-04-29
Review	2014-08-05
Review	2014-08-05
Summary Review	2011-08-12
Letter	2016-07-12
Label	2010-09-10
Label	2014-04-29
Label	2014-04-29
Label	2015-10-06
Label	2015-10-06
Review	2011-08-12
Review	2013-02-25
Review	2013-02-25
Review	2014-08-05
Label	2016-12-21
Label	2016-12-21
Letter	2016-12-21
Letter	2016-12-21
Letter	2017-02-14
Label	2017-02-16
Letter	2017-09-22
REMS	2017-10-12
Label	2018-02-01
Letter	2018-02-02
Letter	2018-06-14
Label	2018-06-19
Medication Guide	2018-06-20
Letter	2018-10-29
Letter	2019-10-09
Label	2019-10-09
Medication Guide	2019-10-09
Label	2019-10-31
Letter	2019-11-01
Letter	2020-03-04
Letter	2021-03-08
Label	2021-03-08
Medication Guide	2021-03-08
Letter	2021-11-23
Letter	2022-05-04
Letter	2022-06-21
Letter	2022-06-21
Label	2022-06-21
Label	2022-06-21
Medication Guide	2022-06-21
Letter	2022-12-21

Application Sponsors

NDA 022410

INDIVIOR INC

Marketing Status

Prescription	001
Prescription	002
Prescription	003
Prescription	004

Application Products

001	FILM;BUCCAL, SUBLINGUAL	EQ 2MG BASE;EQ 0.5MG BASE	1	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
002	FILM;BUCCAL, SUBLINGUAL	EQ 8MG BASE;EQ 2MG BASE	1	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
003	FILM;BUCCAL, SUBLINGUAL	EQ 4MG BASE;EQ 1MG BASE	1	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
004	FILM;BUCCAL, SUBLINGUAL	EQ 12MG BASE;EQ 3MG BASE	1	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2010-08-30	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2014-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2012-08-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2012-08-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2013-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2014-03-12	STANDARD
LABELING; Labeling	SUPPL	15	AP	2013-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2014-06-05	STANDARD
LABELING; Labeling	SUPPL	17	AP	2014-04-28	UNKNOWN
EFFICACY; Efficacy	SUPPL	18	AP	2014-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2014-08-12	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	2015-09-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2015-06-23	STANDARD
REMS; REMS	SUPPL	22	AP	2015-09-22	N/A
EFFICACY; Efficacy	SUPPL	23	AP	2017-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2016-04-15	STANDARD
REMS; REMS	SUPPL	25	AP	2016-07-07	N/A
LABELING; Labeling	SUPPL	26	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	27	AP	2016-12-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2017-01-12	STANDARD
REMS; REMS	SUPPL	29	AP	2017-09-19	STANDARD
REMS; REMS	SUPPL	30	AP	2017-09-19	N/A
LABELING; Labeling	SUPPL	31	AP	2018-02-01	STANDARD
REMS; REMS	SUPPL	33	AP	2018-06-11	N/A
LABELING; Labeling	SUPPL	34	AP	2019-10-31	STANDARD
REMS; REMS	SUPPL	35	AP	2018-10-26	N/A
LABELING; Labeling	SUPPL	38	AP	2019-10-07	STANDARD
REMS; REMS	SUPPL	39	AP	2020-03-02	N/A
LABELING; Labeling	SUPPL	42	AP	2021-03-04	STANDARD
REMS; REMS	SUPPL	44	AP	2021-11-19	N/A
REMS; REMS	SUPPL	45	AP	2022-05-03	N/A
LABELING; Labeling	SUPPL	46	AP	2022-06-17	STANDARD
LABELING; Labeling	SUPPL	47	AP	2022-06-17	STANDARD
REMS; REMS	SUPPL	48	AP	2022-12-16	N/A

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	6
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	6
SUPPL	16	Null	0
SUPPL	17	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	0
SUPPL	20	Null	15
SUPPL	21	Null	0
SUPPL	22	Null	15
SUPPL	23	Null	6
SUPPL	24	Null	0
SUPPL	25	Null	15
SUPPL	26	Null	15
SUPPL	27	Null	6
SUPPL	30	Orphan	5
SUPPL	31	Null	6
SUPPL	33	Null	15
SUPPL	34	Null	15
SUPPL	35	Null	6
SUPPL	38	Orphan	5
SUPPL	39	Null	6
SUPPL	42	Null	7
SUPPL	44	Null	7
SUPPL	45	Null	7
SUPPL	46	Null	15
SUPPL	47	Null	6
SUPPL	48	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

INDIVIOR INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22410
            [companyName] => INDIVIOR INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022410s038lbl.pdf#page=32"]
            [products] => [{"drugName":"SUBOXONE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 2MG BASE;EQ 0.5MG BASE","dosageForm":"FILM;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SUBOXONE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 8MG BASE;EQ 2MG BASE","dosageForm":"FILM;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SUBOXONE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 4MG BASE;EQ 1MG BASE","dosageForm":"FILM;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SUBOXONE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 12MG BASE;EQ 3MG BASE","dosageForm":"FILM;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/31\/2019","submission":"SUPPL-34","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020733s024,022410s034lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2019","submission":"SUPPL-34","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020733s024,022410s034lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-38","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022410s038lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022410s038lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2018","submission":"SUPPL-33","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022410s033,020732s019,020733s023lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2018","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022410s031lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2017","submission":"SUPPL-23","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022410s023lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022410s026s027lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-26","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022410s026s027lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022410s026s027lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2015","submission":"SUPPL-22","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022410s020s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2015","submission":"SUPPL-20","supplementCategories":"Efficacy-New Route Of Administration","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022410s020s022lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2014","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022410s004s017s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2014","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022410s004s017s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2014","submission":"SUPPL-4","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022410s004s017s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022410s015lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2012","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022410s006s007lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/10\/2012","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022410s006s007lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/30\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022410s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SUBOXONE","submission":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","actionType":"EQ 2MG BASE;EQ 0.5MG BASE","submissionClassification":"FILM;BUCCAL, SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SUBOXONE","submission":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","actionType":"EQ 8MG BASE;EQ 2MG BASE","submissionClassification":"FILM;BUCCAL, SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SUBOXONE","submission":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","actionType":"EQ 4MG BASE;EQ 1MG BASE","submissionClassification":"FILM;BUCCAL, SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SUBOXONE","submission":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","actionType":"EQ 12MG BASE;EQ 3MG BASE","submissionClassification":"FILM;BUCCAL, SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-31
        )

)

NDA 022410

INDIVIOR INC

FDA Drug Application

Application #022410

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

INDIVIOR INC