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Serving 500+ biopharmaceutical companies globally:

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Baxter
US Department of Justice
Chinese Patent Office
Healthtrust
Covington
Novartis
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Boehringer Ingelheim

Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201166

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NDA 201166 describes TOPOTECAN HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds Ltd, Accord Hlthcare, Actavis Totowa, Mylan Labs Ltd, Teva Pharms Usa, Ingenus Pharms Llc, Chem Werth Inc, Fresenius Kabi Oncol, Hospira Inc, Sagent Pharms, Fresenius Kabi Usa, Dr Reddys Labs Ltd, and Cipla Ltd, 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 NDA: 201166

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/VIAL
Approval Date:Aug 8, 2012TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Deloitte
Fuji
Chubb
Accenture
AstraZeneca
Argus Health
Mallinckrodt
Teva
Cantor Fitzgerald
QuintilesIMS

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