General MedicationsORALStandard

OXYCODONE AND ACETAMINOPHEN

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Standard Dose

300MG/5ML;10MG/5ML

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview OXYCODONE AND ACETAMINOPHEN is listed in Drugs@FDA under application 202142 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 300MG/5ML;10MG/5ML Sponsor MIKART Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview OXYCODONE AND ACETAMINOPHEN is listed in Drugs@FDA under application 202142 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 300MG/5ML;10MG/5ML Sponsor MIKART 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.