General MedicationsINJECTIONGeneric

TOTECT

DEXRAZOXANE HYDROCHLORIDE

Standard Dose

EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 TOTECT is listed in Drugs@FDA under application 022025 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient DEXRAZOXANE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor CLINIGEN Submission history Latest submission status date: 2022-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview TOTECT is listed in Drugs@FDA under application 022025 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient DEXRAZOXANE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor CLINIGEN Submission history Latest submission status date: 2022-04-29 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.