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General MedicationsBUCCAL, SUBLINGUALStandard

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Standard Dose
EQ 8MG BASE;EQ 2MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE is listed in Drugs@FDA under application 219850 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE Form and strength FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE Sponsor ASCENT PHARMS INC Submission history Latest submission status date: 2026-01-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE is listed in Drugs@FDA under application 219850 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE Form and strength FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE Sponsor ASCENT PHARMS INC Submission history Latest submission status date: 2026-01-21 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.