General MedicationsORALGeneric

RYZOLT

TRAMADOL HYDROCHLORIDE

Standard Dose

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 RYZOLT is listed in Drugs@FDA under application 021745 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient TRAMADOL HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor PURDUE PHARMA Submission history Latest submission status date: 2008-12-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview RYZOLT is listed in Drugs@FDA under application 021745 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient TRAMADOL HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor PURDUE PHARMA Submission history Latest submission status date: 2008-12-30 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.