Data as of 2026-07-12 — 788,886 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
2026-07-12 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"}