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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
Johnson and Johnson
McKinsey
AstraZeneca
Novartis
Fuji
Medtronic
Citi
QuintilesIMS

Generated: December 16, 2017

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 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 090620

Tradename:1
Applicant:1
Ingredient:1
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 25021-824-06 1 VIAL in 1 CARTON (25021-824-06) > 4 mL in 1 VIAL
TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 090620 ANDA Actavis Pharma, Inc. 45963-615 45963-615-56 1 VIAL in 1 CARTON (45963-615-56) > 4 mL in 1 VIAL

Summary 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 leading biopharmaceutical companies globally:

Fish and Richardson
US Army
McKesson
Chubb
Federal Trade Commission
Express Scripts
Cipla
Harvard Business School
Boehringer Ingelheim
Covington

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