Data as of 2026-07-12 — 788,886 rows loaded

020571

NDA PFIZER INC
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CAMPTOSAR IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription AP ✓ ✓
002 CAMPTOSAR IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription AP ✓ ✓
003 CAMPTOSAR IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 300MG/15ML (20MG/ML) Prescription AP ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 56 AP 2024-04-04 MANUF (CMC) N/A
SUPPL 53 AP 2022-01-27 LABELING STANDARD
SUPPL 52 AP 2022-01-27 LABELING STANDARD
SUPPL 51 AP 2020-01-30 LABELING STANDARD
SUPPL 50 AP 2019-02-22 LABELING STANDARD
SUPPL 48 AP 2014-12-19 LABELING STANDARD
SUPPL 47 AP 2014-06-09 MANUF (CMC) PRIORITY
SUPPL 44 AP 2013-01-17 MANUF (CMC) PRIORITY
SUPPL 42 AP 2012-07-13 LABELING STANDARD
SUPPL 37 AP 2010-05-14 LABELING UNKNOWN
SUPPL 36 AP 2010-05-14 LABELING STANDARD
SUPPL 33 AP 2010-05-14 LABELING STANDARD
SUPPL 32 AP 2010-05-14 LABELING STANDARD
SUPPL 31 AP 2010-05-14 LABELING STANDARD
SUPPL 30 AP 2006-08-01 LABELING STANDARD
SUPPL 28 AP 2005-07-21 LABELING STANDARD
SUPPL 27 AP 2005-07-21 LABELING STANDARD
SUPPL 24 AP 2005-07-21 LABELING STANDARD
SUPPL 26 AP 2005-06-07 LABELING STANDARD
SUPPL 23 AP 2004-12-03 LABELING STANDARD
SUPPL 21 AP 2004-06-24 EFFICACY PRIORITY
SUPPL 17 AP 2002-07-30 MANUF (CMC) PRIORITY
SUPPL 16 AP 2002-05-16 LABELING STANDARD
SUPPL 14 AP 2001-11-05 MANUF (CMC) PRIORITY
SUPPL 13 AP 2001-08-06 MANUF (CMC) PRIORITY
SUPPL 11 AP 2000-07-29 MANUF (CMC) PRIORITY
SUPPL 9 AP 2000-04-20 EFFICACY PRIORITY
SUPPL 8 AP 1998-10-22 EFFICACY PRIORITY
SUPPL 7 AP 1998-03-18 LABELING STANDARD
SUPPL 6 AP 1998-01-15 MANUF (CMC) PRIORITY
SUPPL 2 AP 1997-12-10 MANUF (CMC) PRIORITY
SUPPL 5 AP 1997-10-21 MANUF (CMC) PRIORITY
SUPPL 3 AP 1997-06-05 MANUF (CMC) PRIORITY
SUPPL 4 AP 1997-03-07 LABELING STANDARD
SUPPL 1 AP 1997-01-03 LABELING STANDARD
ORIG 1 AP 1996-06-14 TYPE 1 PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2024-05-20 Label SUPPL-56 0
2024-05-20 Letter SUPPL-56 0
2022-01-31 Letter SUPPL-53 0
2022-01-31 Label SUPPL-53 0
2020-01-31 Letter SUPPL-51 0
2020-01-31 Label SUPPL-51 0
2019-02-25 Label SUPPL-50 0
2019-02-15 Review ORIG-1 0
2015-01-09 Label SUPPL-48 0
2014-12-23 Letter SUPPL-48 0
2012-07-25 Label SUPPL-42 0
2012-07-17 Letter SUPPL-42 0
2010-05-28 Label SUPPL-31 0
2010-05-28 Label SUPPL-32 0
2010-05-28 Label SUPPL-37 0
2010-05-28 Label SUPPL-33 0
2010-05-28 Label SUPPL-36 0
2010-05-21 Letter SUPPL-31 0
2010-05-21 Letter SUPPL-33 0
2010-05-21 Letter SUPPL-36 0
2010-05-21 Letter SUPPL-32 0
2010-05-21 Letter SUPPL-37 0
2007-07-06 Review SUPPL-7 0
2007-07-06 Review SUPPL-6 0
2006-08-04 Letter SUPPL-30 0
2006-08-04 Label SUPPL-30 0
2005-07-26 Letter SUPPL-24 0
2005-07-26 Letter SUPPL-27 0
2005-07-26 Label SUPPL-28 0
2005-07-26 Letter SUPPL-28 0
2005-07-26 Label SUPPL-24 0
2005-07-26 Label SUPPL-27 0
2005-06-08 Letter SUPPL-26 0
2005-06-08 Label SUPPL-26 0
2005-04-05 Review SUPPL-21 0
2004-12-08 Letter SUPPL-23 0
2004-12-08 Label SUPPL-23 0
2004-06-25 Letter SUPPL-21 0
2004-06-25 Label SUPPL-21 0
2002-05-16 Label SUPPL-16 0
2002-05-16 Letter SUPPL-16 0
2000-04-20 Letter SUPPL-9 0
2000-04-20 Label SUPPL-9 0
2000-04-20 Review SUPPL-9 0
1998-10-22 Label SUPPL-8 0
1998-10-22 Letter SUPPL-8 0
1998-10-22 Review SUPPL-8 0
1900-01-01 Pediatric Written Request SUPPL-21 0
1900-01-01 Pediatric Medical Review SUPPL-21 0
1900-01-01 Pediatric Clinical Pharmacology Review SUPPL-21 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "53", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "42", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "50", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "3"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "48", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "51", "ActionTypes_LookupID": "48"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "8"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "56", "ActionTypes_LookupID": "36"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "52", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "44", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "47", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "53", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "51", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "50", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "48", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "47", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "44", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "42", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "37", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "36", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "32", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "31", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "21", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020571", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "020571", "ProductNo": "003", "TECode": "AP"}
2026-07-12 te INSERT {"ApplNo": "020571", "ProductNo": "002", "TECode": "AP"}
2026-07-12 te INSERT {"ApplNo": "020571", "ProductNo": "001", "TECode": "AP"}
2026-07-12 marketing_status INSERT {"ApplNo": "020571", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "020571", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "020571", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "26"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "32"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "36"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "42"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "44"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "47"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "48"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "50"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "51"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "52"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "53"}
2026-07-12 submissions INSERT {"ApplNo": "020571", "SubmissionType": "SUPPL", "SubmissionNo": "56"}
2026-07-12 products INSERT {"ApplNo": "020571", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "020571", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "020571", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020571"}