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

761430

BLA JANSSEN BIOTECH
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 IMAAVY NIPOCALIMAB-AAHU INJECTABLE;INJECTION 300MG/1.62ML(185MG/ML) Prescription
002 IMAAVY NIPOCALIMAB-AAHU INJECTABLE;INJECTION 1200MG/6.5ML(185MG/ML) Prescription
Special Designations
Orphan (Sub 1)
Submissions
Type#StatusDate ClassReview PriorityNotes
ORIG 1 AP 2025-04-29 TYPE 1 PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2025-06-02 Review ORIG-1 0
2025-05-05 Letter ORIG-1 0
2025-04-30 Label ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761430", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761430", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Orphan"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761430", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "761430", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "761430", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "761430", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "761430", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "761430", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "761430"}