FDA.reportPublic FDA data

Application 204242

Type
NDA
Sponsor
OREXO US INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZUBSOLVBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 1.4MG BASE;EQ 0.36MG BASEYesNo
002ZUBSOLVBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 5.7MG BASE;EQ 1.4MG BASEYesNo
003ZUBSOLVBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 8.6MG BASE;EQ 2.1MG BASEYesNo
004ZUBSOLVBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 11.4MG BASE;EQ 2.9MG BASEYesYes
005ZUBSOLVBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 2.9MG BASE;EQ 0.71MG BASEYesNo
006ZUBSOLVBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 0.7MG BASE;EQ 0.18MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54123-114Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-114Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-114Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-114Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-114Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-907Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-907Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-907Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-907Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-907Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-914Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-914Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-914Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-914Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-914Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-929Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-929Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-929Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-929Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-929Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-957Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-957Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-957Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-957Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-957Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-986Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-986Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-986Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-986Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent
54123-986Zubsolvbuprenorphine hydrochloride and naloxone hydrochlorideOrexo US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84658SUPPL 2026-01-06
84577SUPPL 2025-12-29
82212SUPPL 2025-05-21
82237SUPPL 2025-05-19
81361SUPPL 2025-02-25
77895SUPPL 2024-03-21
77075SUPPL 2023-12-19
76967SUPPL 2023-12-18
76966SUPPL 2023-12-18
73854SUPPL 2023-03-24
73839SUPPL 2023-03-24
73065SUPPL2022-12-29
71397SUPPL2022-06-21
71396SUPPL2022-06-21
71395SUPPL2022-06-21
71374SUPPL2022-06-21
71373SUPPL2022-06-21
70974SUPPL2022-05-04
66645SUPPL2021-03-08
66644SUPPL2021-03-08
66610SUPPL2021-03-08
60478SUPPL2019-10-09
60477SUPPL2019-10-09
60460SUPPL2019-10-09
56297SUPPL2018-11-06
52289SUPPL2018-02-02
52244SUPPL2018-02-01
49709SUPPL2017-09-11
49708SUPPL2017-09-11
48521SUPPL2017-05-25
46436SUPPL2016-12-21
46433SUPPL2016-12-21
45598SUPPL2016-10-07
45505SUPPL2016-10-06
32530SUPPL2016-07-12
40367SUPPL2015-08-11
32527SUPPL2015-08-11
32529SUPPL2015-06-10
19536SUPPL2015-06-10
32528SUPPL2015-02-17
19535SUPPL2015-02-03
10312SUPPL2014-12-12
43459ORIG2014-06-27
32526SUPPL2013-09-09
44591ORIG2013-07-23
10311ORIG2013-07-08
40366ORIG2013-07-05