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General MedicationsSUBCUTANEOUSStandard

SUBLOCADE

BUPRENORPHINE

Standard Dose
100MG/0.5ML (100MG/0.5ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SUBLOCADE is listed in Drugs@FDA under application 209819 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BUPRENORPHINE Form and strength SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS - 100MG/0.5ML (100MG/0.5ML) Sponsor INDIVIOR Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview SUBLOCADE is listed in Drugs@FDA under application 209819 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUPRENORPHINE Form and strength SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS - 100MG/0.5ML (100MG/0.5ML) Sponsor INDIVIOR 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.
SUBLOCADE (BUPRENORPHINE) | Drug Monograph | MedicHelpline