General MedicationsORALGeneric

COMBUNOX

IBUPROFEN; OXYCODONE HYDROCHLORIDE

Standard Dose

400MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 COMBUNOX is listed in Drugs@FDA under application 021378 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient IBUPROFEN; OXYCODONE HYDROCHLORIDE Form and strength TABLET;ORAL - 400MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor FOREST LABS Submission history Latest submission status date: 2010-09-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview COMBUNOX is listed in Drugs@FDA under application 021378 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient IBUPROFEN; OXYCODONE HYDROCHLORIDE Form and strength TABLET;ORAL - 400MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor FOREST LABS Submission history Latest submission status date: 2010-09-02 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.