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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Mallinckrodt
Cantor Fitzgerald
Argus Health
Merck
Fuji
Covington
Accenture
Harvard Business School

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203054

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NDA 203054 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-three 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 203054
Tradename:IRINOTECAN HYDROCHLORIDE
Applicant:Intas Pharms Usa
Ingredient:irinotecan hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/2ML (20MG/ML)
Approval Date:Aug 31, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/5ML (20MG/ML)
Approval Date:Aug 31, 2017TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
AstraZeneca
Baxter
Cerilliant
Chubb
US Department of Justice
Julphar
Harvard Business School

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