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

KARBINAL ER

CARBINOXAMINE MALEATE

Standard Dose
4MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview KARBINAL ER is listed in Drugs@FDA under application 022556 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CARBINOXAMINE MALEATE Form and strength SUSPENSION, EXTENDED RELEASE;ORAL - 4MG/5ML Sponsor AYTU Submission history Latest submission status date: 2026-03-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview KARBINAL ER is listed in Drugs@FDA under application 022556 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CARBINOXAMINE MALEATE Form and strength SUSPENSION, EXTENDED RELEASE;ORAL - 4MG/5ML Sponsor AYTU Submission history Latest submission status date: 2026-03-10 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.