Home Applications 020733 Application 020733
Type NDA
Sponsor INDIVIOR INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020733-001 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2002-10-08 N020733-002 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2002-10-08
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 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N020733-001 SUBOXONE EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2002-10-08 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020733-002 SUBOXONE EQ 8MG BASE;EQ 2MG BASE TABLET / SUBLINGUAL RLD 2002-10-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020733-001 SUBOXONE EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2002-10-08 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020733-002 SUBOXONE EQ 8MG BASE;EQ 2MG BASE TABLET / SUBLINGUAL RLD 2002-10-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020733-001 SUBOXONE EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2002-10-08 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020733-002 SUBOXONE EQ 8MG BASE;EQ 2MG BASE TABLET / SUBLINGUAL RLD 2002-10-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020733-001 SUBOXONE EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2002-10-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020733-002 SUBOXONE EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / SUBLINGUAL RLD 2002-10-08 a50c72e98297…
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Suboxone BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE INDIVIOR INC. 8a5edcf9-828c-4f97-b671-268ab13a8ecd 2025-12-22 Warnings, Adverse reactions Name fallback brand name: Suboxone
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.