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General MedicationsORALGeneric

ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN; CODEINE PHOSPHATE

Standard Dose
120MG/5ML;12MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview ACETAMINOPHEN AND CODEINE PHOSPHATE is listed in Drugs@FDA under application 091238 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; CODEINE PHOSPHATE Form and strength SOLUTION;ORAL - 120MG/5ML;12MG/5ML Sponsor CHARTWELL MOLECULAR Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview ACETAMINOPHEN AND CODEINE PHOSPHATE is listed in Drugs@FDA under application 091238 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; CODEINE PHOSPHATE Form and strength SOLUTION;ORAL - 120MG/5ML;12MG/5ML Sponsor CHARTWELL MOLECULAR 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.