Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsSUBLINGUALGeneric

SUBOXONE

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Standard Dose
EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview SUBOXONE is listed in Drugs@FDA under application 020733 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE Form and strength TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor INDIVIOR Submission history Latest submission status date: 2022-06-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview SUBOXONE is listed in Drugs@FDA under application 020733 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE Form and strength TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor INDIVIOR Submission history Latest submission status date: 2022-06-17 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE) | Drug Monograph | MedicHelpline