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

200671

NDA HESP
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 DURLAZA ASPIRIN CAPSULE, EXTENDED RELEASE;ORAL 162.5MG Discontinued ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 2 AP 2015-09-30 LABELING STANDARD
SUPPL 1 AP 2015-09-15 LABELING STANDARD
ORIG 1 AP 2015-09-04 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2016-09-30 Review ORIG-1 0
2015-12-10 Label SUPPL-2 0
2015-10-22 Label SUPPL-1 0
2015-10-02 Letter SUPPL-2 0
2015-09-17 Letter SUPPL-1 0
2015-09-15 Letter ORIG-1 0
2015-09-14 Label ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-09-09 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-09-09 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-09 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-08 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-09-08 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-04 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-09-04 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-02 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-09-02 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-01 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-09-01 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-31 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-31 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-28 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-28 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-26 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-08-25 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-08-25 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-24 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-08-24 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-21 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-08-21 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-20 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-08-20 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-20 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-19 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-08-19 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-19 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-18 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-08-17 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-14 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-14 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-13 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-12 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-12 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-11 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-11 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-10 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-10 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-07 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-05 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-08-05 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-04 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-08-04 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-04 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-31 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-31 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-31 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-29 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-29 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-29 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-28 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-27 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-27 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-24 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-23 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-23 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-22 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-22 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-22 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-17 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-17 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-15 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-15 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-15 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-14 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-14 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-14 submission_property_type UPDATE {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 submission_property_type INSERT {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "200671", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "200671", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "200671", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "200671", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "200671"}