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Chubb
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201191

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NDA 201191 describes TOPOTECAN HYDROCHLORIDE, which is a drug marketed by 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 fifteen NDAs. It is available from eleven suppliers. Additional details are available on the TOPOTECAN HYDROCHLORIDE profile page.

The generic ingredient in TOPOTECAN HYDROCHLORIDE is topotecan hydrochloride. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
Summary for 201191
Tradename:TOPOTECAN HYDROCHLORIDE
Applicant:Dr Reddys Labs Ltd
Ingredient:topotecan hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201191
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 201191
Suppliers and Packaging for NDA: 201191
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 201191 ANDA Bedford Laboratories 55390-370 N 55390-370-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/VIAL
Approval Date:Mar 9, 2011TE:APRLD:No

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Cipla
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Chinese Patent Office
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Harvard Business School

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