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

761497

BLA EMERGE BIOSCIENCE PTE. LTD.
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 GARZULYS INSULIN ASPART-FSAN PEN;PREFILLED 3ML Prescription
002 GARZULYS INSULIN ASPART-FSAN VIAL; MULTIDOSE 10ML Prescription
Submissions
Type#StatusDate ClassReview PriorityNotes
ORIG 1 AP 2026-07-24 UNKNOWN STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2026-07-28 Letter ORIG-1 0
2026-07-28 Label ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-09-09 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-08 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-08 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-04 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-04 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-02 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-02 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-01 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-01 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-31 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-28 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-28 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-26 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-26 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-25 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-25 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-24 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-21 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-21 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-20 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-20 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-19 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-19 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-18 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-18 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-17 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-17 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-14 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-13 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-13 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-12 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-12 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-11 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-11 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-10 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-07 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-07 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-05 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-05 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-04 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-04 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-31 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-31 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-29 join_submission_action_types UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-29 submission_property_type UPDATE {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-29 marketing_status INSERT {"ApplNo": "761497", "ProductNo": "002"}
2026-07-29 marketing_status INSERT {"ApplNo": "761497", "ProductNo": "001"}
2026-07-29 products INSERT {"ApplNo": "761497", "ProductNo": "002"}
2026-07-29 products INSERT {"ApplNo": "761497", "ProductNo": "001"}
2026-07-29 applications INSERT {"ApplNo": "761497"}
2026-07-28 join_submission_action_types INSERT {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-28 submission_property_type INSERT {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-28 submissions INSERT {"ApplNo": "761497", "SubmissionType": "ORIG", "SubmissionNo": "1"}