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

761484

BLA JANSSEN BIOTECH
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 RYBREVANT FASPRO AMIVANTAMAB AND HYALURONIDASE-LPUJ VIAL; SINGLE-USE 1,600MG/20,000 UNITS PER 10ML Prescription
002 RYBREVANT FASPRO AMIVANTAMAB AND HYALURONIDASE-LPUJ VIAL; SINGLE-USE 2,240MG/28,000 UNITS PER 14ML Prescription
003 RYBREVANT FASPRO AMIVANTAMAB AND HYALURONIDASE-LPUJ VIAL; SINGLE-USE 2,400MG/30,000 UNITS PER 15ML Prescription
004 RYBREVANT FASPRO AMIVANTAMAB AND HYALURONIDASE-LPUJ VIAL; SINGLE-USE 3,5200MG/44,000 UNITS PER 22ML Prescription
Submissions
Type#StatusDate ClassReview PriorityNotes
ORIG 1 AP 2026-02-13 TYPE 5 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2026-02-20 Letter ORIG-1 0
2026-02-20 Label ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761484", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761484", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "761484", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "761484", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "761484", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "761484", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "761484", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "761484", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "761484", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "761484", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "761484", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "761484"}