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

761425

BLA SAMSUNG BIOEPIS CO LTD
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 PYZCHIVA USTEKINUMAB-TTWE INJECTABLE;SUBCUTANEOUS 130MG/26ML(5MG/ML) Prescription
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 5 AP 2025-11-18 LABELING STANDARD
ORIG 2 AP 2025-04-30 TYPE 3 STANDARD
SUPPL 3 AP 2025-03-13 LABELING STANDARD
SUPPL 1 AP 2024-12-20 MANUF (CMC) N/A
SUPPL 2 AP 2024-12-20 MANUF (CMC) STANDARD
ORIG 1 AP 2024-06-28 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2025-11-19 Letter SUPPL-5 0
2025-11-19 Label SUPPL-5 0
2025-11-19 Medication Guide SUPPL-5 0
2025-10-30 Review ORIG-2 0
2025-09-17 Summary Review SUPPL-1 0
2025-08-25 Label SUPPL-1 0
2025-08-22 Label ORIG-1 0
2025-08-22 Letter ORIG-2 0
2025-04-30 Label ORIG-2 0
2025-03-17 Label SUPPL-3 0
2025-03-17 Letter SUPPL-3 0
2025-02-05 Review ORIG-1 0
2024-12-26 Letter SUPPL-1 0
2024-12-26 Label SUPPL-2 0
2024-07-08 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761425", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761425", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761425", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761425", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761425", "SubmissionType": "ORIG", "SubmissionNo": "2", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761425", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761425", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761425", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761425", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761425", "SubmissionType": "ORIG", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761425", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "761425", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "761425", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "761425", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "761425", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "761425", "SubmissionType": "ORIG", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "761425", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "761425", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "761425", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "761425"}