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General MedicationsINJECTIONStandard

ORABLOC

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Standard Dose
4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ORABLOC is listed in Drugs@FDA under application 022466 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Form and strength INJECTABLE;INJECTION - 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) Sponsor PIERREL Submission history Latest submission status date: 2025-07-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview ORABLOC is listed in Drugs@FDA under application 022466 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Form and strength INJECTABLE;INJECTION - 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) Sponsor PIERREL Submission history Latest submission status date: 2025-07-02 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.