Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsINJECTIONStandard

FLAVALTA

EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE

Standard Dose
EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview FLAVALTA is listed in Drugs@FDA under application 216564 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE Form and strength SOLUTION;INJECTION - EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML) Sponsor DEPROCO Submission history Latest submission status date: 2026-03-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview FLAVALTA is listed in Drugs@FDA under application 216564 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE Form and strength SOLUTION;INJECTION - EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML) Sponsor DEPROCO Submission history Latest submission status date: 2026-03-19 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.