General MedicationsORALGeneric

XARTEMIS XR

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Standard Dose

325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 XARTEMIS XR is listed in Drugs@FDA under application 204031 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor MALLINCKRODT INC Submission history Latest submission status date: 2018-09-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview XARTEMIS XR is listed in Drugs@FDA under application 204031 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor MALLINCKRODT INC Submission history Latest submission status date: 2018-09-18 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.