General MedicationsINTRAVENOUSGeneric

TOPOTECAN HYDROCHLORIDE

Standard Dose

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview TOPOTECAN HYDROCHLORIDE is listed in Drugs@FDA under application 206074 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient TOPOTECAN HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Sponsor NATCO PHARMA USA Submission history Latest submission status date: 2020-08-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview TOPOTECAN HYDROCHLORIDE is listed in Drugs@FDA under application 206074 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient TOPOTECAN HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Sponsor NATCO PHARMA USA Submission history Latest submission status date: 2020-08-06 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.