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General MedicationsINTRAVENOUSGeneric

TOPOTECAN

TOPOTECAN HYDROCHLORIDE

Standard Dose
EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 TOPOTECAN is listed in Drugs@FDA under application 200199 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient TOPOTECAN HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SANDOZ INC Submission history Latest submission status date: 2014-02-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview TOPOTECAN is listed in Drugs@FDA under application 200199 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient TOPOTECAN HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SANDOZ INC Submission history Latest submission status date: 2014-02-28 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
TOPOTECAN (TOPOTECAN HYDROCHLORIDE) | Drug Monograph | MedicHelpline