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

018841

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
004 DAYPRO OXAPROZIN TABLET;ORAL 600MG Discontinued AB ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 36 AP 2024-11-21 LABELING STANDARD
SUPPL 34 AP 2022-11-09 LABELING STANDARD
SUPPL 33 AP 2021-04-28 LABELING STANDARD
SUPPL 30 AP 2019-05-03 LABELING STANDARD
SUPPL 28 AP 2016-05-09 LABELING STANDARD
SUPPL 22 AP 2007-06-21 LABELING STANDARD
SUPPL 21 AP 2006-01-18 LABELING STANDARD
SUPPL 20 AP 2003-04-10 LABELING STANDARD
SUPPL 16 AP 2002-01-25 EFFICACY STANDARD
SUPPL 12 AP 2002-01-25 LABELING STANDARD
SUPPL 18 AP 2000-09-08 MANUF (CMC) STANDARD
SUPPL 17 AP 2000-02-22 MANUF (CMC) STANDARD
SUPPL 15 AP 1998-01-06 LABELING STANDARD
SUPPL 14 AP 1998-01-06 LABELING STANDARD
SUPPL 9 AP 1998-01-06 LABELING STANDARD
SUPPL 7 AP 1998-01-06 LABELING STANDARD
SUPPL 11 AP 1997-05-08 MANUF (CMC) STANDARD
SUPPL 6 AP 1996-09-10 MANUF (CMC) STANDARD
SUPPL 8 AP 1996-06-13 MANUF (CMC) STANDARD
SUPPL 10 AP 1996-06-11 MANUF (CMC) STANDARD
SUPPL 3 AP 1995-11-03 MANUF (CMC) STANDARD
SUPPL 5 AP 1995-04-06 LABELING STANDARD
SUPPL 4 AP 1995-02-22 LABELING STANDARD
SUPPL 2 AP 1993-12-27 LABELING STANDARD
SUPPL 1 AP 1993-04-02 LABELING STANDARD
ORIG 1 AP 1992-10-29 TYPE 1 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2024-11-25 Label SUPPL-36 0
2024-11-25 Medication Guide SUPPL-36 0
2024-11-22 Letter SUPPL-36 0
2022-11-09 Label SUPPL-34 0
2021-04-30 Label SUPPL-33 0
2021-04-29 Letter SUPPL-33 0
2019-05-06 Letter SUPPL-30 0
2019-05-06 Label SUPPL-30 0
2016-05-12 Letter SUPPL-28 0
2016-05-11 Label SUPPL-28 0
2014-05-07 Label SUPPL-22 0
2007-07-05 Letter SUPPL-22 0
2006-01-20 Letter SUPPL-21 0
2006-01-20 Label SUPPL-21 0
2004-06-02 Letter SUPPL-20 0
2003-04-17 Label SUPPL-20 0
2002-01-25 Letter SUPPL-12 0
2002-01-25 Label SUPPL-16 0
2002-01-25 Letter SUPPL-16 0
2002-01-25 Label SUPPL-12 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "34", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "9"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "34"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "36", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "34", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "018841", "ProductNo": "004", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "018841", "ProductNo": "004"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "34"}
2026-07-12 submissions INSERT {"ApplNo": "018841", "SubmissionType": "SUPPL", "SubmissionNo": "36"}
2026-07-12 products INSERT {"ApplNo": "018841", "ProductNo": "004"}
2026-07-12 applications INSERT {"ApplNo": "018841"}