NDA 018401

INDIVIOR INC

FDA Drug Application

Application #018401

Documents

• Letter: 2002-03-08
• Letter: 2003-06-22
• Review: 2006-05-10
• Review: 2006-10-26
• Letter: 2016-12-19
• Label: 2019-10-07
• Letter: 2019-10-09
• Letter: 2022-06-21
• Label: 2022-06-21

Application Sponsors

NDA 018401

INDIVIOR INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.3MG BASE/ML

1

BUPRENEX

BUPRENORPHINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1981-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-10-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-05-17	STANDARD
LABELING; Labeling	SUPPL	4	AP	1987-02-13
LABELING; Labeling	SUPPL	5	AP	1987-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-12-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-04-29	STANDARD
LABELING; Labeling	SUPPL	11	AP	1993-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-11-29	STANDARD
LABELING; Labeling	SUPPL	14	AP	2002-02-11	STANDARD
LABELING; Labeling	SUPPL	15	AP	2003-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2013-01-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2014-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2013-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2015-05-11	STANDARD
LABELING; Labeling	SUPPL	22	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	25	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	26	AP	2022-06-17	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	15
SUPPL	25	Null	6
SUPPL	26	Null	7

TE Codes

001

Prescription

AP

CDER Filings

INDIVIOR INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18401
            [companyName] => INDIVIOR INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPRENEX","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE","strength":"EQ 0.3MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018401s025lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BUPRENEX","submission":"BUPRENORPHINE HYDROCHLORIDE","actionType":"EQ 0.3MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)