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Details for New Drug Application (NDA): 090137

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NDA 090137 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: 090137

Tradename:
IRINOTECAN HYDROCHLORIDE
Applicant:
Sandoz Inc
Ingredient:
irinotecan hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 090137

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 090137

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRINOTECAN HYDROCHLORIDE
irinotecan hydrochloride
INJECTABLE;INJECTION 090137 ANDA Sandoz Inc 66758-048 66758-048-01 1 VIAL, SINGLE-DOSE in 1 CARTON (66758-048-01) > 2 mL in 1 VIAL, SINGLE-DOSE
IRINOTECAN HYDROCHLORIDE
irinotecan hydrochloride
INJECTABLE;INJECTION 090137 ANDA Sandoz Inc 66758-048 66758-048-02 1 VIAL, SINGLE-DOSE in 1 CARTON (66758-048-02) > 5 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/2ML (20MG/ML)
Approval Date:Nov 12, 2009TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/5ML (20MG/ML)
Approval Date:Nov 12, 2009TE:APRLD:No


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