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General MedicationsORALStandard

PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE

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

Approval overview PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE is listed in Drugs@FDA under application 090180 (ANDA).

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

Structured Monograph

Clinical summary

Approval overview PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE is listed in Drugs@FDA under application 090180 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE Form and strength SYRUP; ORAL - 10MG; 5ML Sponsor CHARTWELL RX 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.