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Serving hundreds of leading biopharmaceutical companies globally:

Dow
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Chinese Patent Office
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Generated: May 23, 2018

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Details for New Drug Application (NDA): 200582

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NDA 200582 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 nine 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. Twelve suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
Summary for 200582
Tradename:TOPOTECAN HYDROCHLORIDE
Applicant:Hospira Inc
Ingredient:topotecan hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200582
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 200582
Suppliers and Packaging for NDA: 200582
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 200582 NDA Hospira, Inc. 0409-0302 N 0409-0302-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date:Feb 2, 2011TE:APRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Cantor Fitzgerald
Harvard Business School
Merck
Farmers Insurance
Queensland Health
Mallinckrodt
Colorcon
Cipla

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