Data as of 2026-09-09 — 792,868 rows loaded

020418

NDA MCNEIL PED
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 MOTRIN IBUPROFEN TABLET;ORAL 100MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 3 AP 2002-02-04 LABELING STANDARD
SUPPL 4 AP 2001-05-14 MANUF (CMC) STANDARD
SUPPL 1 AP 1995-03-24 EFFICACY STANDARD
ORIG 1 AP 1994-11-16 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2006-05-08 Review SUPPL-3 0
2002-02-04 Letter SUPPL-3 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020418", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "8"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020418", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020418", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020418", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020418", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020418", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020418", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "020418", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020418", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020418", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020418", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "020418", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 products INSERT {"ApplNo": "020418", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020418"}