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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Daiichi Sankyo
Citi
QuintilesIMS
Mallinckrodt
Queensland Health
Chubb
US Department of Justice

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090620

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NDA 090620 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 090620
Tradename:TOPOTECAN HYDROCHLORIDE
Applicant:Actavis Totowa
Ingredient:topotecan hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090620
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 090620
Suppliers and Packaging for NDA: 090620
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 090620 ANDA Sagent Pharmaceuticals 25021-824 N 25021-824-06
TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 090620 ANDA Actavis Pharma, Inc. 45963-615 N 45963-615-56

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/VIAL
Approval Date:Dec 2, 2010TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Cerilliant
Daiichi Sankyo
Covington
Citi
Cipla
Medtronic
Harvard Business School
Accenture

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