FDA.reportPublic FDA data

Application 018401

Type
NDA
Sponsor
INDIVIOR INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPRENEXBUPRENORPHINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 0.3MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12496-0757Buprenexbuprenorphine hydrochlorideReckitt Benckiser Pharmaceuticals IncNDACurrent
12496-0757Buprenexbuprenorphine hydrochlorideIndivior Inc.NDACurrent
12496-0757Buprenexbuprenorphine hydrochlorideIndivior Inc.NDACurrent
12496-0757Buprenexbuprenorphine hydrochlorideIndivior Inc.NDACurrent
12496-0757Buprenexbuprenorphine hydrochlorideIndivior Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76984SUPPL 2023-12-19
76885SUPPL 2023-12-18
71408SUPPL2022-06-21
71363SUPPL2022-06-21
60413SUPPL2019-10-09
60269SUPPL2019-10-07
46214SUPPL2016-12-19
40797SUPPL2006-10-26
20124SUPPL2006-05-10
14996SUPPL2003-06-22
14995SUPPL2002-03-08