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

761458

BLA GLAXOSMITHKLINE LLC
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 EXDENSUR DEPEMOKIMAB-ULAA INJECTION 100MG Prescription
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 2 AP 2026-06-10 LABELING STANDARD
ORIG 1 AP 2025-12-16 TYPE 1 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2026-06-11 Letter SUPPL-2 0
2026-01-26 Review ORIG-1 0
2026-01-15 Label ORIG-1 0
2025-12-19 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761458", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761458", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "19"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761458", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761458", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "761458", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "761458", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "761458", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "761458", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "761458"}