Data as of 2026-07-13 — 788,886 rows loaded

020601

NDA KENVUE BRANDS
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CHILDREN'S MOTRIN IBUPROFEN TABLET, CHEWABLE;ORAL 50MG Discontinued ✓
003 JUNIOR STRENGTH MOTRIN IBUPROFEN TABLET, CHEWABLE;ORAL 100MG Discontinued ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 21 AP 2018-10-02 LABELING STANDARD
SUPPL 20 AP 2017-05-15 LABELING STANDARD
SUPPL 18 AP 2010-10-18 LABELING UNKNOWN
SUPPL 17 AP 2009-04-28 LABELING STANDARD
SUPPL 14 AP 2006-05-10 LABELING STANDARD
SUPPL 13 AP 2006-02-27 LABELING STANDARD
SUPPL 7 AP 2002-08-05 MANUF (CMC) STANDARD
SUPPL 6 AP 2001-05-02 MANUF (CMC) STANDARD
SUPPL 5 AP 1999-12-29 LABELING STANDARD
SUPPL 4 AP 1999-12-29 MANUF (CMC) STANDARD
SUPPL 2 AP 1999-09-13 LABELING STANDARD
SUPPL 3 AP 1998-12-18 MANUF (CMC) STANDARD
SUPPL 1 AP 1998-06-12 LABELING STANDARD
ORIG 1 AP 1996-11-15 TYPE 8 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2018-10-11 Label SUPPL-21 0
2018-10-11 Letter SUPPL-21 0
2017-05-17 Label SUPPL-20 0
2017-05-17 Letter SUPPL-20 0
2010-10-20 Letter SUPPL-18 0
2009-05-04 Letter SUPPL-17 0
2006-05-16 Letter SUPPL-14 0
2006-03-01 Letter SUPPL-13 0
1999-09-13 Letter SUPPL-2 0
1999-09-13 Label SUPPL-2 0
1999-09-13 Review SUPPL-2 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "15"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "21", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "20", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "020601", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "020601", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "020601", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 products INSERT {"ApplNo": "020601", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "020601", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020601"}