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General MedicationsBUCCALStandard

BELBUCA

BUPRENORPHINE HYDROCHLORIDE

Standard Dose
EQ 0.6MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BELBUCA is listed in Drugs@FDA under application 207932 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BUPRENORPHINE HYDROCHLORIDE Form and strength FILM;BUCCAL - EQ 0.6MG BASE Sponsor BDSI Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview BELBUCA is listed in Drugs@FDA under application 207932 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUPRENORPHINE HYDROCHLORIDE Form and strength FILM;BUCCAL - EQ 0.6MG BASE Sponsor BDSI Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.