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

761467

BLA MERCK SHARP DOHME
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 KEYTRUDA QLEX PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH INJECTABLE;INJECTION 395MG/4800UNITS(2.4ML) Prescription
002 KEYTRUDA QLEX PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH INJECTABLE;INJECTION 790MG/9600UNITS(4.8ML) Prescription
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 4 AP 2026-06-24 EFFICACY STANDARD
SUPPL 9 AP 2026-06-12 EFFICACY PRIORITY
SUPPL 7 AP 2026-05-12 LABELING STANDARD
SUPPL 3 AP 2026-04-24 EFFICACY STANDARD
SUPPL 13 AP 2026-04-06 LABELING STANDARD
SUPPL 2 AP 2026-02-10 EFFICACY PRIORITY
SUPPL 1 AP 2025-11-21 EFFICACY PRIORITY
ORIG 1 AP 2025-09-19 TYPE 1 PRIORITY
ORIG 2 AP 2025-09-19 EFFICACY PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2026-06-29 Label SUPPL-4 0
2026-06-29 Medication Guide SUPPL-9 0
2026-06-26 Letter SUPPL-4 0
2026-06-18 Medication Guide SUPPL-4 0
2026-06-17 Label SUPPL-9 0
2026-06-16 Letter SUPPL-9 0
2026-05-18 Label SUPPL-7 0
2026-05-13 Letter SUPPL-7 0
2026-04-28 Label SUPPL-3 0
2026-04-27 Letter SUPPL-3 0
2026-04-08 Label SUPPL-13 0
2026-04-07 Letter SUPPL-13 0
2026-02-12 Label SUPPL-2 0
2026-02-12 Letter SUPPL-2 0
2025-11-25 Label SUPPL-1 0
2025-11-25 Medication Guide SUPPL-1 0
2025-11-24 Letter SUPPL-1 0
2025-10-06 Letter ORIG-1 0
2025-10-06 Letter ORIG-2 0
2025-10-06 Review ORIG-2 0
2025-10-06 Review ORIG-1 0
2025-09-22 Label ORIG-1 0
2025-09-22 Medication Guide ORIG-1 0
2025-09-22 Medication Guide ORIG-2 0
2025-09-22 Label ORIG-2 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "8"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761467", "SubmissionType": "ORIG", "SubmissionNo": "2", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "8"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761467", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761467", "SubmissionType": "ORIG", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761467", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "761467", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "761467", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "761467", "SubmissionType": "ORIG", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "761467", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "761467", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "761467", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "761467", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "761467"}