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

020802

NDA HALEON US HOLDINGS
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 EXCEDRIN (MIGRAINE RELIEF) ACETAMINOPHEN; ASPIRIN; CAFFEINE TABLET;ORAL 250MG;250MG;65MG Over-the-counter ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 42 AP 2023-05-15 MANUF (CMC) N/A
SUPPL 43 AP 2023-04-17 LABELING STANDARD
SUPPL 40 AP 2021-12-07 MANUF (CMC) N/A
SUPPL 38 AP 2021-11-03 LABELING STANDARD
SUPPL 34 AP 2020-02-27 LABELING STANDARD
SUPPL 33 AP 2019-04-15 LABELING STANDARD
SUPPL 32 AP 2018-01-02 LABELING STANDARD
SUPPL 31 AP 2017-10-12 LABELING STANDARD
SUPPL 30 AP 2017-09-13 MANUF (CMC) STANDARD
SUPPL 28 AP 2016-04-29 MANUF (CMC) STANDARD
SUPPL 27 AP 2016-01-28 MANUF (CMC) STANDARD
SUPPL 26 AP 2015-11-17 MANUF (CMC) STANDARD
SUPPL 25 AP 2014-07-30 MANUF (CMC) STANDARD
SUPPL 24 AP 2014-07-15 LABELING STANDARD
SUPPL 22 AP 2014-04-15 LABELING STANDARD
SUPPL 19 AP 2010-02-04 LABELING STANDARD
SUPPL 15 AP 2007-01-31 LABELING STANDARD
SUPPL 10 AP 2004-08-27 MANUF (CMC) STANDARD
SUPPL 9 AP 2003-05-21 LABELING STANDARD
SUPPL 7 AP 2002-04-19 MANUF (CMC) STANDARD
SUPPL 6 AP 2000-10-10 MANUF (CMC) STANDARD
SUPPL 4 AP 2000-09-07 LABELING STANDARD
SUPPL 5 AP 2000-04-26 MANUF (CMC) STANDARD
SUPPL 2 AP 1999-10-07 EFFICACY STANDARD
SUPPL 3 AP 1999-08-20 MANUF (CMC) STANDARD
SUPPL 1 AP 1998-10-22 MANUF (CMC) STANDARD
ORIG 1 AP 1998-01-14 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2023-05-16 Letter SUPPL-42 0
2023-05-16 Label SUPPL-42 0
2023-04-19 Label SUPPL-43 0
2023-04-19 Letter SUPPL-43 0
2021-12-13 Label SUPPL-40 0
2021-12-09 Letter SUPPL-40 0
2021-11-09 Label SUPPL-38 0
2021-11-04 Letter SUPPL-38 0
2020-02-28 Label SUPPL-34 0
2020-02-28 Letter SUPPL-34 0
2019-04-19 Label SUPPL-32 0
2019-04-16 Letter SUPPL-33 0
2019-04-16 Label SUPPL-33 0
2018-01-09 Letter SUPPL-32 0
2017-10-27 Label SUPPL-31 0
2017-10-18 Letter SUPPL-31 0
2014-07-30 Label SUPPL-24 0
2014-07-17 Letter SUPPL-24 0
2014-04-22 Label SUPPL-22 0
2014-04-17 Letter SUPPL-22 0
2010-02-17 Letter SUPPL-19 0
2007-02-12 Letter SUPPL-15 0
2005-07-13 Review ORIG-1 0
2004-08-31 Letter SUPPL-10 0
2003-06-08 Letter SUPPL-9 0
2003-06-08 Label SUPPL-9 0
1999-10-07 Letter SUPPL-2 0
1999-10-07 Label SUPPL-2 0
1999-10-07 Review SUPPL-2 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "34", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "8"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "43", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "42", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "43", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "38", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "34", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "32", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "31", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "26", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "25", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "24", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "020802", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "26"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "32"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "34"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "42"}
2026-07-12 submissions INSERT {"ApplNo": "020802", "SubmissionType": "SUPPL", "SubmissionNo": "43"}
2026-07-12 products INSERT {"ApplNo": "020802", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020802"}