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Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200199

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NDA 200199 describes TOPOTECAN, which is a drug marketed by Sandoz Inc, Accord Hlthcare, Actavis Totowa, Cipla Ltd, Dr Reddys Labs Ltd, Fresenius Kabi Oncol, Fresenius Kabi Usa, Hong Kong, Mylan Labs Ltd, Novast Labs Ltd, Sagent Pharms, Sun Pharm Inds Ltd, Hospira Inc, and Teva Pharms Usa, and is included in sixteen NDAs. It is available from one supplier. Additional details are available on the TOPOTECAN profile page.

The generic ingredient in TOPOTECAN is topotecan hydrochloride. There are ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
Summary for 200199
Tradename:TOPOTECAN
Applicant:Sandoz Inc
Ingredient:topotecan hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200199
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 200199
Suppliers and Packaging for NDA: 200199
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPOTECAN topotecan hydrochloride SOLUTION;INTRAVENOUS 200199 NDA Sandoz Inc 66758-051 E 66758-051-01
TOPOTECAN topotecan hydrochloride SOLUTION;INTRAVENOUS 200199 NDA Sandoz Inc 66758-051 E 66758-051-03

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 25, 2011TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 25, 2011TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 25, 2011TE:RLD:Yes

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