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Serving leading biopharmaceutical companies globally:

Queensland Health
Boehringer Ingelheim
Express Scripts
Accenture
Harvard Business School
Covington
Baxter
US Department of Justice
Julphar
Medtronic

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078188

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NDA 078188 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 078188

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

Pharmacology for NDA: 078188

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 078188

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078188 ANDA Fresenius Kabi USA, LLC 63323-193 63323-193-02 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-193-02) > 2 mL in 1 VIAL, SINGLE-DOSE
IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078188 ANDA Fresenius Kabi USA, LLC 63323-193 63323-193-05 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-193-05) > 5 mL in 1 VIAL, SINGLE-DOSE

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


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Serving leading biopharmaceutical companies globally:

Baxter
Cipla
Cerilliant
Moodys
Johnson and Johnson
Dow
Fish and Richardson
Cantor Fitzgerald
Federal Trade Commission
Fuji

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