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

761400

BLA RENGENERON PHARMACEUTICALS, INC.
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 LYNOZYFIC LINVOSELTAMAB-GCPT SOLUTION; INJECTION 5MG/2ML Prescription
Special Designations
Orphan (Sub 1) Orphan (Sub 3)
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 3 AP 2026-07-31 REMS N/A
ORIG 1 AP 2025-07-02 TYPE 1 PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2026-08-04 Letter SUPPL-3 0
2025-07-28 Review ORIG-1 0
2025-07-09 Medication Guide ORIG-1 0
2025-07-08 Label ORIG-1 0
2025-07-02 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-09-09 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-09 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-09-08 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-08 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-09-08 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-09-08 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-04 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-04 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-09-04 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-02 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-02 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-09-02 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-09-02 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-01 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-01 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-09-01 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-31 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-31 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-31 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-31 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-28 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-28 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-28 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-28 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-26 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-26 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-26 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-26 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-25 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-25 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-25 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-25 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-24 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-24 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-24 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-24 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-21 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-21 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-21 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-21 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-20 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-20 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-20 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-20 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-19 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-19 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-19 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-19 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-18 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-18 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-18 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-18 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-17 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-17 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-17 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-17 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-14 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-14 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-14 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-14 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-13 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-13 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-13 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-13 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-12 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-12 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-12 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-11 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-11 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-11 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-10 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-10 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-10 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-10 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-07 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-07 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-07 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-07 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-05 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-05 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-05 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-05 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-04 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-04 join_submission_action_types INSERT {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "55"}
2026-08-04 submission_property_type INSERT {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Orphan"}
2026-08-04 submission_property_type INSERT {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-08-04 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-04 submissions INSERT {"ApplNo": "761400", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-31 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-31 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-29 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-29 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-28 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-28 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-27 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-27 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-24 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-24 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-23 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-22 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-22 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-17 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-15 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-15 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-14 join_submission_action_types UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-14 submission_property_type UPDATE {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Orphan"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "761400", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "761400", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "761400", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "761400"}