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Generated: May 27, 2017

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Details for New Drug Application (NDA): 202351

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NDA 202351 describes TOPOTECAN HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds Ltd, Actavis Totowa, Mylan Labs Ltd, Accord Hlthcare, 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 thirteen 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

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 202351

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
topotecan hydrochloride
INJECTABLE;INJECTION 202351 ANDA Accord Healthcare, Inc. 16729-151 16729-151-31 1 VIAL in 1 PACKAGE (16729-151-31) > 4 mL in 1 VIAL

Summary for product number 001

Approval Date:Jun 26, 2013TE:APRLD:No

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