Generated: September 22, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 202351
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: 202351
|Formulation / Manufacturing:||see details|
Pharmacology for NDA: 202351
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Summary for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||INJECTABLE;INJECTION||Strength||EQ 4MG BASE/VIAL|
|Approval Date:||Jun 26, 2013||TE:||AP||RLD:||No|
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