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Express Scripts
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091284

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NDA 091284 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 091284
Tradename:TOPOTECAN HYDROCHLORIDE
Applicant:Sagent Pharms
Ingredient:topotecan hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091284
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 091284
Suppliers and Packaging for NDA: 091284
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091284 ANDA Sagent Pharmaceuticals 25021-206 N 25021-206-06
TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091284 ANDA Sagent Pharmaceuticals 25021-206 N 25021-206-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/VIAL
Approval Date:Jan 26, 2011TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
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Merck
Chubb
Mallinckrodt
UBS
Daiichi Sankyo
US Army
Dow

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