FDA.reportPublic FDA data

Application 020732

Type
NDA
Sponsor
INDIVIOR INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SUBUTEXBUPRENORPHINE HYDROCHLORIDETABLET;SUBLINGUALEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003SUBUTEXBUPRENORPHINE HYDROCHLORIDETABLET;SUBLINGUALEQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-4092Buprenorphine hydrochlorideBuprenorphine hydrochloridebryant ranch prepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71388SUPPL2022-06-21
71387SUPPL2022-06-21
71386SUPPL2022-06-21
71365SUPPL2022-06-21
71364SUPPL2022-06-21
70983SUPPL2022-05-04
69378SUPPL2021-11-23
66583SUPPL2021-03-08
66582SUPPL2021-03-08
66503SUPPL2021-03-05
62026SUPPL2020-03-04
60770SUPPL2019-11-01
60768SUPPL2019-10-31
60767SUPPL2019-10-31
60469SUPPL2019-10-09
60467SUPPL2019-10-09
60357SUPPL2019-10-08
56143SUPPL2018-10-29
54618SUPPL2018-06-20
54612SUPPL2018-06-19
54595SUPPL2018-06-14
52286SUPPL2018-02-02
52249SUPPL2018-02-01
49841SUPPL2017-09-22
49807SUPPL2017-09-20
49696SUPPL2017-09-08
46369SUPPL2016-12-21
46368SUPPL2016-12-21
46263SUPPL2016-12-20
46262SUPPL2016-12-20
3224SUPPL2016-07-12
25655SUPPL2015-09-24
13308SUPPL2014-12-18
25654SUPPL2014-12-12
23979ORIG2012-01-05
25653SUPPL2012-01-03
3223SUPPL2012-01-03
35247SUPPL2011-12-23
13307SUPPL2011-12-23
3222SUPPL2006-10-13
41624ORIG2004-11-22
13306ORIG2002-10-08
3221ORIG2002-10-08