Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020571


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NDA 020571 describes CAMPTOSAR, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from one supplier. Additional details are available on the CAMPTOSAR profile page.

The generic ingredient in CAMPTOSAR is irinotecan hydrochloride. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.
Summary for 020571
Tradename:CAMPTOSAR
Applicant:Pfizer Inc
Ingredient:irinotecan hydrochloride
Patents:0
Pharmacology for NDA: 020571
Mechanism of ActionTopoisomerase Inhibitors
Suppliers and Packaging for NDA: 020571
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571 NDA Pharmacia & Upjohn Company LLC 0009-0082 0009-0082-02 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0082-02) / 15 mL in 1 VIAL, SINGLE-DOSE
CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571 NDA Pharmacia & Upjohn Company LLC 0009-0112 0009-0112-05 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0112-05) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/2ML (20MG/ML)
Approval Date:Jun 14, 1996TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/5ML (20MG/ML)
Approval Date:Jun 14, 1996TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength300MG/15ML (20MG/ML)
Approval Date:Aug 5, 2010TE:APRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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