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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cerilliant
Chinese Patent Office
Cipla
Baxter
Mallinckrodt
Accenture
Farmers Insurance
Fuji
Boehringer Ingelheim

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203380

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NDA 203380 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 203380

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

Pharmacology for NDA: 203380

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 203380

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 203380 ANDA Apotex Corp. 60505-6128 60505-6128-1 1 VIAL, SINGLE-USE in 1 CARTON (60505-6128-1) > 5 mL in 1 VIAL, SINGLE-USE
IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 203380 ANDA Apotex Corp. 60505-6128 60505-6128-0 1 VIAL, SINGLE-USE in 1 CARTON (60505-6128-0) > 2 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/2ML (20MG/ML)
Approval Date:May 3, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/5ML (20MG/ML)
Approval Date:May 3, 2016TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength300MG/15ML (20MG/ML)
Approval Date:May 3, 2016TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Moodys
Merck
Express Scripts
Farmers Insurance
Novartis
Dow
Baxter
Accenture
Citi

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