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General MedicationsORALStandard

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Standard Dose
10MG/5ML;6.25MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE is listed in Drugs@FDA under application 214238 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE Form and strength SYRUP;ORAL - 10MG/5ML;6.25MG/5ML Sponsor QUAGEN Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE is listed in Drugs@FDA under application 214238 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE Form and strength SYRUP;ORAL - 10MG/5ML;6.25MG/5ML Sponsor QUAGEN Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.