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Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091089

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NDA 091089 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 ten 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. Thirteen suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
Summary for 091089
Applicant:Fresenius Kabi Usa
Ingredient:topotecan hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 091089
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 091089
Suppliers and Packaging for NDA: 091089
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091089 ANDA Fresenius Kabi USA, LLC 63323-762 N 63323-762-10
TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091089 ANDA Fresenius Kabi USA, LLC 63323-762 N 63323-762-17

Profile for product number 001

Approval Date:Nov 29, 2010TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo

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