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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200771

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NDA 200771 describes IRINOTECAN HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Akorn, Cipla Ltd, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Oncol, Fresenius Kabi Usa, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Ingenus Pharms Llc, Intas Pharms Usa, Jiangsu Hengrui Med, Mustafa Nevzat Ilac, Pliva Lachema, Qilu Pharm Co Ltd, Sandoz, Sandoz Inc, Sun Pharma Global, Teva Pharms Usa, and West-ward Pharms Int, and is included in twenty-three NDAs. It is available from fourteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

Summary for 200771

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 200771

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 200771

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 200771 ANDA Heritage Pharmaceuticals Inc. 23155-179 23155-179-32 1 VIAL in 1 CARTON (23155-179-32) > 5 mL in 1 VIAL
IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 200771 ANDA Heritage Pharmaceuticals Inc. 23155-179 23155-179-31 1 VIAL in 1 CARTON (23155-179-31) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/2ML (20MG/ML)
Approval Date:Feb 14, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/5ML (20MG/ML)
Approval Date:Feb 14, 2012TE:APRLD:No


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