General MedicationsORALStandard

ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN; CODEINE PHOSPHATE

Standard Dose

300MG;30MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ACETAMINOPHEN AND CODEINE PHOSPHATE is listed in Drugs@FDA under application 212418 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; CODEINE PHOSPHATE Form and strength TABLET;ORAL - 300MG;30MG Sponsor ELITE LABS INC 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 212418 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; CODEINE PHOSPHATE Form and strength TABLET;ORAL - 300MG;30MG Sponsor ELITE LABS INC 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.