BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Accenture
Chubb
Moodys
Daiichi Sankyo
Novartis
Argus Health
Healthtrust
Boehringer Ingelheim
UBS
Harvard Business School

Generated: January 18, 2018

DrugPatentWatch Database Preview

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 fourteen 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 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 0409-0302-01 1 VIAL, SINGLE-USE in 1 CARTON (0409-0302-01) > 4 mL in 1 VIAL, SINGLE-USE
TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 200582 NDA Hospira, Inc. 0409-0302 0409-0302-25 1 VIAL, SINGLE-USE in 1 CARTON (0409-0302-25) > 4 mL in 1 VIAL, SINGLE-USE

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 leading biopharmaceutical companies globally:

Fish and Richardson
Deloitte
Novartis
McKesson
Cipla
Fuji
Covington
US Army
Teva

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