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General MedicationsBUCCALGeneric

BUNAVAIL

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Standard Dose
EQ 4.2MG BASE;EQ 0.7MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Discontinued
Summary

Approval overview BUNAVAIL is listed in Drugs@FDA under application 205637 (NDA).

Review priority: N/A Marketing status: Discontinued Active ingredient BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE Form and strength FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE Sponsor BDSI Submission history Latest submission status date: 2022-12-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview BUNAVAIL is listed in Drugs@FDA under application 205637 (NDA). Review priority: N/A Marketing status: Discontinued Active ingredient BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE Form and strength FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE Sponsor BDSI Submission history Latest submission status date: 2022-12-16 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.