Application Information

This drug has been submitted to the FDA under the reference 022453/001.

Names and composition

"TOPOTECAN HYDROCHLORIDE" is the commercial name of a drug composed of TOPOTECAN HYDROCHLORIDE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
022453/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE SOLUTION/INTRAVENOUS EQ 4MG BASE per 4ML (EQ 1MG BASE per ML)
090620/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
091089/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
091199/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
091284/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
091376/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
091542/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
200582/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE SOLUTION/INTRAVENOUS EQ 4MG BASE per 4ML (EQ 1MG BASE per ML)
201166/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
201191/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
202203/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
202351/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
204406/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE SOLUTION/INTRAVENOUS EQ 1MG BASE per ML (EQ 1MG BASE per ML)
204406/002 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE SOLUTION/INTRAVENOUS EQ 4MG BASE per 4ML (EQ 1MG BASE per ML)
206962/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
020671/001 HYCAMTIN TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
020981/001 HYCAMTIN TOPOTECAN HYDROCHLORIDE CAPSULE/ORAL EQ 0.25MG BASE
020981/002 HYCAMTIN TOPOTECAN HYDROCHLORIDE CAPSULE/ORAL EQ 1MG BASE
022453/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE SOLUTION/INTRAVENOUS EQ 4MG BASE per 4ML (EQ 1MG BASE per ML)
090620/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
091089/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
091199/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
091284/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
091376/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
091542/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
200199/001 TOPOTECAN TOPOTECAN HYDROCHLORIDE SOLUTION/INTRAVENOUS EQ 1MG BASE per ML (EQ 1MG BASE per ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
200199/002 TOPOTECAN TOPOTECAN HYDROCHLORIDE SOLUTION/INTRAVENOUS EQ 3MG BASE per 3ML (EQ 1MG BASE per ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
200199/003 TOPOTECAN TOPOTECAN HYDROCHLORIDE SOLUTION/INTRAVENOUS EQ 4MG BASE per 4ML (EQ 1MG BASE per ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
200582/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE SOLUTION/INTRAVENOUS EQ 4MG BASE per 4ML (EQ 1MG BASE per ML)
201166/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
201191/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
202203/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
202351/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL
204406/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE SOLUTION/INTRAVENOUS EQ 1MG BASE per ML (EQ 1MG BASE per ML)
204406/002 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE SOLUTION/INTRAVENOUS EQ 4MG BASE per 4ML (EQ 1MG BASE per ML)
206962/001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE/INJECTION EQ 4MG BASE per VIAL

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