FDA.reportPublic FDA data

Application 020733

Type
NDA
Sponsor
INDIVIOR INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUBOXONEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002SUBOXONEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 8MG BASE;EQ 2MG BASEYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020733-001SUBOXONEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08
N020733-002SUBOXONEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALRLD2002-10-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / SUBLINGUALRLD2002-10-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALRLD2002-10-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / SUBLINGUALRLD2002-10-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALRLD2002-10-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020733-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / SUBLINGUALRLD2002-10-08782e0a99824c…
2021-12-28 21:50 UTC2021-12N020733-002SUBOXONEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALRLD2002-10-08782e0a99824c…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SuboxoneBUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDEINDIVIOR INC.8a5edcf9-828c-4f97-b671-268ab13a8ecd2025-12-22Warnings, Adverse reactionsName fallback
brand name: Suboxone

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71391SUPPL2022-06-21
71390SUPPL2022-06-21
71389SUPPL2022-06-21
71367SUPPL2022-06-21
71366SUPPL2022-06-21
70984SUPPL2022-05-04
69379SUPPL2021-11-23
66621SUPPL2021-03-08
66620SUPPL2021-03-08
66504SUPPL2021-03-05
62027SUPPL2020-03-04
61011SUPPL2019-11-21
61008SUPPL2019-11-21
60771SUPPL2019-11-01
60764SUPPL2019-10-31
60424SUPPL2019-10-09
56142SUPPL2018-10-29
54611SUPPL2018-06-19
54594SUPPL2018-06-14
52287SUPPL2018-02-02
52247SUPPL2018-02-01
50047APPL2017-10-12
49840SUPPL2017-09-22
49808SUPPL2017-09-20
49695SUPPL2017-09-08
46367SUPPL2016-12-21
46366SUPPL2016-12-21
46265SUPPL2016-12-20
46264SUPPL2016-12-20
25658SUPPL2016-07-12
3228SUPPL2015-09-24
13311SUPPL2014-12-18
3227SUPPL2014-12-12
25657SUPPL2012-01-03
25656SUPPL2012-01-03
35248SUPPL2011-12-23
13310SUPPL2011-12-23
3226SUPPL2006-10-13
23596ORIG2006-10-11
41625ORIG2004-11-22
13309ORIG2002-10-08
3225ORIG2002-10-08