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

019281

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CYKLOKAPRON TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription AP ✓ ✓
Special Designations
Orphan (Sub 1)
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 48 AP 2025-08-29 LABELING STANDARD
SUPPL 47 AP 2021-02-04 LABELING STANDARD
SUPPL 44 AP 2020-06-07 LABELING STANDARD
SUPPL 41 AP 2017-11-21 LABELING 901 REQUIRED
SUPPL 38 AP 2016-11-03 MANUF (CMC) STANDARD
SUPPL 40 AP 2016-08-01 MANUF (CMC) STANDARD
SUPPL 37 AP 2016-02-01 MANUF (CMC) STANDARD
SUPPL 36 AP 2015-10-20 MANUF (CMC) STANDARD
SUPPL 35 AP 2015-06-01 MANUF (CMC) STANDARD
SUPPL 34 AP 2015-04-17 MANUF (CMC) STANDARD
SUPPL 33 AP 2014-12-15 MANUF (CMC) STANDARD
SUPPL 31 AP 2013-05-10 LABELING STANDARD
SUPPL 30 AP 2011-01-25 LABELING STANDARD
SUPPL 27 AP 2009-01-28 LABELING STANDARD
SUPPL 25 AP 2008-12-22 LABELING STANDARD
SUPPL 19 AP 2002-05-15 MANUF (CMC) STANDARD
SUPPL 18 AP 2002-04-16 MANUF (CMC) STANDARD
SUPPL 17 AP 2001-11-02 MANUF (CMC) STANDARD
SUPPL 16 AP 2001-11-02 MANUF (CMC) STANDARD
SUPPL 15 AP 2001-10-31 LABELING STANDARD
SUPPL 12 AP 2001-07-31 MANUF (CMC) STANDARD
SUPPL 13 AP 2001-03-27 LABELING STANDARD
SUPPL 11 AP 2000-04-28 MANUF (CMC) STANDARD
SUPPL 10 AP 1999-11-15 MANUF (CMC) STANDARD
SUPPL 9 AP 1999-09-09 LABELING STANDARD
SUPPL 3 AP 1996-12-05 MANUF (CMC) STANDARD
SUPPL 8 AP 1996-07-24 MANUF (CMC) STANDARD
SUPPL 7 AP 1996-07-24 MANUF (CMC) STANDARD
SUPPL 5 AP 1996-07-24 MANUF (CMC) STANDARD
SUPPL 4 AP 1996-07-24 MANUF (CMC) STANDARD
SUPPL 1 AP 1996-07-24 MANUF (CMC) STANDARD
SUPPL 6 AP 1994-11-07 MANUF (CMC) STANDARD
SUPPL 2 AP 1994-11-07 MANUF (CMC) STANDARD
ORIG 1 AP 1986-12-30 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2025-09-03 Letter SUPPL-48 0
2025-09-02 Label SUPPL-48 0
2021-05-18 Label SUPPL-47 0
2021-02-05 Letter SUPPL-47 0
2020-06-16 Label SUPPL-44 0
2020-06-08 Letter SUPPL-44 0
2017-11-27 Letter SUPPL-41 0
2017-11-22 Label SUPPL-41 0
2015-04-14 Label SUPPL-33 0
2013-05-14 Letter SUPPL-31 0
2013-05-14 Label SUPPL-31 0
2011-02-02 Letter SUPPL-30 0
2011-01-31 Label SUPPL-30 0
2009-01-30 Letter SUPPL-27 0
2009-01-02 Label SUPPL-25 0
2008-12-24 Letter SUPPL-25 0
2001-06-18 Review SUPPL-9 0
2001-03-27 Letter SUPPL-13 0
1999-09-09 Letter SUPPL-9 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "47", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "44", "ActionTypes_LookupID": "48"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "48", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "47", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "34", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "48", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "47", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "44", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "41", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "40", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "37", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "36", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "35", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "34", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "31", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019281", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Orphan"}
2026-07-12 te INSERT {"ApplNo": "019281", "ProductNo": "001", "TECode": "AP"}
2026-07-12 marketing_status INSERT {"ApplNo": "019281", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "34"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "36"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "44"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "47"}
2026-07-12 submissions INSERT {"ApplNo": "019281", "SubmissionType": "SUPPL", "SubmissionNo": "48"}
2026-07-12 products INSERT {"ApplNo": "019281", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "019281"}