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General MedicationsORALStandard

OXYCODONE AND ACETAMINOPHEN

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Standard Dose
300MG;10MG
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 040608 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Form and strength TABLET;ORAL - 300MG;10MG 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 040608 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Form and strength TABLET;ORAL - 300MG;10MG 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.