PFIZER INC FDA Approval NDA 020571

NDA 020571

PFIZER INC

FDA Drug Application

Application #020571

Documents

Letter2005-07-26
Letter2005-06-08
Letter2005-07-26
Letter2006-08-04
Letter2010-05-21
Letter2010-05-21
Letter2010-05-21
Letter2014-12-23
Label1998-10-22
Label2002-05-16
Label2005-06-08
Label2005-07-26
Label2010-05-28
Label2010-05-28
Label2010-05-28
Label2015-01-09
Review2007-07-06
Review2005-04-05
Letter1998-10-22
Letter2000-04-20
Letter2002-05-16
Letter2004-06-25
Letter2004-12-08
Letter2005-07-26
Letter2010-05-21
Letter2010-05-21
Letter2012-07-17
Label2000-04-20
Label2004-06-25
Label2004-12-08
Label2005-07-26
Label2005-07-26
Label2006-08-04
Label2010-05-28
Label2010-05-28
Label2012-07-25
Review2007-07-06
Review1998-10-22
Review2000-04-20
Pediatric Written Request1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Review2019-02-15
Label2019-02-25
Letter2020-01-31
Label2020-01-31
Letter2022-01-31
Label2022-01-31

Application Sponsors

NDA 020571PFIZER INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION40MG/2ML (20MG/ML)1CAMPTOSARIRINOTECAN HYDROCHLORIDE
002INJECTABLE;INJECTION100MG/5ML (20MG/ML)1CAMPTOSARIRINOTECAN HYDROCHLORIDE
003INJECTABLE;INJECTION300MG/15ML (20MG/ML)1CAMPTOSARIRINOTECAN HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1996-06-14PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1997-12-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1997-06-05PRIORITY
LABELING; LabelingSUPPL4AP1997-03-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1997-10-21PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-01-15PRIORITY
LABELING; LabelingSUPPL7AP1998-03-18STANDARD
EFFICACY; EfficacySUPPL8AP1998-10-22PRIORITY
EFFICACY; EfficacySUPPL9AP2000-04-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2000-07-29PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2001-08-06PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-11-05PRIORITY
LABELING; LabelingSUPPL16AP2002-05-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2002-07-30PRIORITY
EFFICACY; EfficacySUPPL21AP2004-06-24PRIORITY
LABELING; LabelingSUPPL23AP2004-12-03STANDARD
LABELING; LabelingSUPPL24AP2005-07-21STANDARD
LABELING; LabelingSUPPL26AP2005-06-07STANDARD
LABELING; LabelingSUPPL27AP2005-07-21STANDARD
LABELING; LabelingSUPPL28AP2005-07-21STANDARD
LABELING; LabelingSUPPL30AP2006-08-01STANDARD
LABELING; LabelingSUPPL31AP2010-05-14STANDARD
LABELING; LabelingSUPPL32AP2010-05-14STANDARD
LABELING; LabelingSUPPL33AP2010-05-14STANDARD
LABELING; LabelingSUPPL36AP2010-05-14STANDARD
LABELING; LabelingSUPPL37AP2010-05-14UNKNOWN
LABELING; LabelingSUPPL42AP2012-07-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL44AP2013-01-17PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL47AP2014-06-09PRIORITY
LABELING; LabelingSUPPL48AP2014-12-19STANDARD
LABELING; LabelingSUPPL50AP2019-02-22STANDARD
LABELING; LabelingSUPPL51AP2020-01-30STANDARD
LABELING; LabelingSUPPL52AP2022-01-27STANDARD
LABELING; LabelingSUPPL53AP2022-01-27STANDARD

Submissions Property Types

ORIG1Null41
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null41
SUPPL11Null0
SUPPL13Null0
SUPPL14Null0
SUPPL17Null0
SUPPL21Null6
SUPPL31Null7
SUPPL32Null6
SUPPL33Null6
SUPPL36Null7
SUPPL37Null6
SUPPL42Null7
SUPPL44Null0
SUPPL47Null0
SUPPL48Null15
SUPPL50Null15
SUPPL51Null15
SUPPL53Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

PFIZER INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20571
            [companyName] => PFIZER INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAMPTOSAR","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"40MG\/2ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CAMPTOSAR","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"100MG\/5ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CAMPTOSAR","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"300MG\/15ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/30\/2020","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020571s051lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2019","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020571s050lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020571s048lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2012","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020571s042lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2010","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020571s031s032s033s036s037lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2010","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020571s031s032s033s036s037lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2010","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020571s031s032s033s036s037lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2010","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020571s031s032s033s036s037lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2010","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020571s031s032s033s036s037lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2006","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020571s030lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2005","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020571s024,027,028lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2005","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020571s024,027,028lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2005","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020571s024,027,028lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2005","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020571s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2004","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20571s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/24\/2004","submission":"SUPPL-21","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20571se8-021_camptosar_lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2002","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20571s16lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2000","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20571s9lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/1998","submission":"SUPPL-8","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20571s8lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CAMPTOSAR","submission":"IRINOTECAN HYDROCHLORIDE","actionType":"40MG\/2ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CAMPTOSAR","submission":"IRINOTECAN HYDROCHLORIDE","actionType":"100MG\/5ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CAMPTOSAR","submission":"IRINOTECAN HYDROCHLORIDE","actionType":"300MG\/15ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-01-30
        )

)
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