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General MedicationsORALGeneric

ROXICET

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Standard Dose
325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview ROXICET is listed in Drugs@FDA under application 089351 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HIKMA Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview ROXICET is listed in Drugs@FDA under application 089351 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HIKMA Submission history Latest submission status date: 2025-12-22 00:00:00.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.