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Details for New Drug Application (NDA): 091284

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NDA 091284 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: 091284

Formulation / Manufacturing:see details

Pharmacology for NDA: 091284

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 091284

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
topotecan hydrochloride
INJECTABLE;INJECTION 091284 ANDA Sagent Pharmaceuticals 25021-206 25021-206-06 1 VIAL in 1 CARTON (25021-206-06) > 4 mL in 1 VIAL
topotecan hydrochloride
INJECTABLE;INJECTION 091284 ANDA Sagent Pharmaceuticals 25021-206 25021-206-61 5 CARTON in 1 BOX (25021-206-61) > 1 VIAL in 1 CARTON (25021-206-06) > 4 mL in 1 VIAL

Summary for product number 001

Approval Date:Jan 26, 2011TE:APRLD:No

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