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Generated: December 14, 2017

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 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 091089

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 63323-762-94 1 VIAL in 1 BOX (63323-762-94) > 4 mL in 1 VIAL
TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091089 ANDA Fresenius Kabi USA, LLC 63323-762 63323-762-10 1 VIAL in 1 BOX (63323-762-10) > 4 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/VIAL
Approval Date:Nov 29, 2010TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Queensland Health
Boehringer Ingelheim
Johnson and Johnson
Daiichi Sankyo
Express Scripts
Farmers Insurance
Novartis
Chubb
Mallinckrodt
US Army

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