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General MedicationsORALGeneric

OXYCODONE HYDROCHLORIDE AND IBUPROFEN

IBUPROFEN; OXYCODONE HYDROCHLORIDE

Standard Dose
400MG;5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview OXYCODONE HYDROCHLORIDE AND IBUPROFEN is listed in Drugs@FDA under application 078769 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient IBUPROFEN; OXYCODONE HYDROCHLORIDE Form and strength TABLET;ORAL - 400MG;5MG Sponsor ACTAVIS ELIZABETH Submission history Latest submission status date: 2025-12-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview OXYCODONE HYDROCHLORIDE AND IBUPROFEN is listed in Drugs@FDA under application 078769 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient IBUPROFEN; OXYCODONE HYDROCHLORIDE Form and strength TABLET;ORAL - 400MG;5MG Sponsor ACTAVIS ELIZABETH Submission history Latest submission status date: 2025-12-23 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
OXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN; OXYCODONE HYDROCHLORIDE) | Drug Monograph | MedicHelpline