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

CODEINE SULFATE

CODEINE SULFATE

Standard Dose
30MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview CODEINE SULFATE is listed in Drugs@FDA under application 202245 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient CODEINE SULFATE Form and strength SOLUTION;ORAL - 30MG/5ML Sponsor HIKMA Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview CODEINE SULFATE is listed in Drugs@FDA under application 202245 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient CODEINE SULFATE Form and strength SOLUTION;ORAL - 30MG/5ML Sponsor HIKMA Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.