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

020776

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 DAYPRO ALTA OXAPROZIN POTASSIUM TABLET;ORAL 600MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 13 AP 2024-11-21 LABELING STANDARD
SUPPL 11 AP 2022-11-09 LABELING STANDARD
SUPPL 10 AP 2021-04-28 LABELING STANDARD
SUPPL 8 AP 2019-05-03 LABELING STANDARD
SUPPL 6 AP 2016-05-09 LABELING STANDARD
SUPPL 2 AP 2007-07-05 LABELING STANDARD
SUPPL 1 AP 2006-01-18 LABELING STANDARD
ORIG 1 AP 2002-10-17 TYPE 2 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2024-11-25 Label SUPPL-13 0
2024-11-25 Medication Guide SUPPL-13 0
2024-11-22 Letter SUPPL-13 0
2022-11-09 Label SUPPL-11 0
2021-05-03 Label SUPPL-10 0
2021-04-29 Letter SUPPL-10 0
2019-05-07 Letter SUPPL-8 0
2019-05-06 Label SUPPL-8 0
2016-05-12 Letter SUPPL-6 0
2016-05-11 Label SUPPL-6 0
2007-07-10 Letter SUPPL-2 0
2006-01-20 Letter SUPPL-1 0
2006-01-20 Label SUPPL-1 0
2005-04-27 Review ORIG-1 0
2002-10-17 Label ORIG-1 0
2002-10-17 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020776", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "020776", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020776", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "020776", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 products INSERT {"ApplNo": "020776", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020776"}