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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Army
Medtronic
UBS
Farmers Insurance
Moodys
Fish and Richardson
Citi
Healthtrust

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202351

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NDA 202351 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. Eleven suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
Summary for 202351
Tradename:TOPOTECAN HYDROCHLORIDE
Applicant:Accord Hlthcare
Ingredient:topotecan hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202351
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 202351
Suppliers and Packaging for NDA: 202351
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 202351 ANDA Accord Healthcare, Inc. 16729-151 N 16729-151-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/VIAL
Approval Date:Jun 26, 2013TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Citi
Colorcon
UBS
Johnson and Johnson
Chubb
Federal Trade Commission
Julphar
Chinese Patent Office

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