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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018401-001BUPRENEXBUPRENORPHINE HYDROCHLORIDEEQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N018401-001BUPRENEXEQ 0.3MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018401-001BUPRENEXEQ 0.3MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018401-001BUPRENEXEQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018401-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018401-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018401-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018401-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018401-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018401-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018401-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N018401-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018401-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018401-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018401-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N018401-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018401-001AP1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018401-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018401-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018401-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018401-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018401-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018401-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018401-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018401-001AP1cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEAdvagen Pharma Ltd699638dd-3a53-445f-a545-d0e6eabfe1c92026-07-17Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEREMEDYREPACK INC.11686845-f5fd-4e96-8a4f-9b132bf488402026-07-07Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma442831cf-9636-433a-9a12-e9a8cd31f72a2026-02-28Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
BELBUCABUPRENORPHINE HYDROCHLORIDEBioDelivery Sciences International Incbc2b7a3d-72cf-497c-95b0-ba2b71f63c642026-01-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEHospira, Inc.23aa1bb3-cecf-4e62-29bb-48488bb66fc32025-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEPar Health USA, LLC34767dda-ce52-4f98-a45f-bb5cee0cd5e62025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEA-S Medication Solutionsc1398d85-d4bb-4426-8ecf-a50400910d812025-05-28Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.adc1167e-910e-4d7b-abdc-751d3df0c3dc2025-03-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDESomerset Therapeutics, LLC74e40c51-853b-4e7f-b3cb-a27af29e1cbf2025-02-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

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