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Details for New Drug Application (NDA): 078589

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NDA 078589 describes IRINOTECAN HYDROCHLORIDE, which is a drug marketed by Teva Pharms Usa, Sun Pharma Global, Hospira, Hisun Pharm Hangzhou, Cipla Ltd, Pliva Lachema, Akorn, Hikma Farmaceutica, Sandoz Inc, Dr Reddys Labs Ltd, Eurohlth Intl Sarl, Accord Hlthcare, Emcure Pharms Ltd, Jiangsu Hengrui Med, Fresenius Kabi Usa, Qilu Pharm Co Ltd, Fresenius Kabi Oncol, Actavis Totowa, Mustafa Nevzat Ilac, and Sandoz, and is included in twenty-one NDAs. It is available from thirteen suppliers. Additional details are available on the IRINOTECAN HYDROCHLORIDE profile page.

The generic ingredient in IRINOTECAN HYDROCHLORIDE is irinotecan hydrochloride. There are thirty-two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

Summary for NDA: 078589

Actavis Totowa
irinotecan hydrochloride

Pharmacology for NDA: 078589

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 078589

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
irinotecan hydrochloride
INJECTABLE;INJECTION 078589 ANDA Sagent Pharmaceuticals 25021-214 25021-214-02 1 VIAL in 1 CARTON (25021-214-02) > 2 mL in 1 VIAL
irinotecan hydrochloride
INJECTABLE;INJECTION 078589 ANDA Sagent Pharmaceuticals 25021-214 25021-214-05 1 VIAL in 1 CARTON (25021-214-05) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/2ML (20MG/ML)
Approval Date:Feb 27, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/5ML (20MG/ML)
Approval Date:Feb 27, 2008TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/25ML (20MG/ML)
Approval Date:Nov 18, 2015TE:APRLD:No

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