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

761118

BLA PFIZER INC
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 ABRILADA ADALIMUMAB-AFZB INJECTABLE;INJECTION 40MG/0.8ML Prescription
002 ABRILADA ADALIMUMAB-AFZB INJECTABLE;INJECTION 20MG/0.4ML Prescription
003 ABRILADA ADALIMUMAB-AFZB INJECTABLE;INJECTION 10MG/0.2ML Prescription
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 20 AP 2025-12-17 TYPE 2 STANDARD
SUPPL 12 AP 2024-04-30 LABELING STANDARD
SUPPL 7 AP 2023-10-04 EFFICACY STANDARD
SUPPL 11 AP 2023-08-16 BIOEQUIV N/A
SUPPL 9 AP 2023-06-14 EFFICACY STANDARD
SUPPL 6 AP 2022-07-29 EFFICACY STANDARD
ORIG 1 AP 2019-11-15 TYPE 2 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2025-12-22 Label SUPPL-20 0
2025-12-19 Letter SUPPL-20 0
2024-03-15 Label SUPPL-12 0
2024-03-15 Letter SUPPL-12 0
2023-10-06 Label SUPPL-7 0
2023-10-06 Medication Guide SUPPL-7 0
2023-10-05 Letter SUPPL-7 0
2023-08-18 Label SUPPL-11 0
2023-08-17 Letter SUPPL-11 0
2023-06-15 Letter SUPPL-9 0
2023-06-15 Label SUPPL-9 0
2022-08-01 Letter SUPPL-6 0
2022-08-01 Label SUPPL-6 0
2020-01-28 Review ORIG-1 0
2019-11-19 Letter ORIG-1 0
2019-11-18 Label ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "8"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "9"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761118", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "1"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "761118", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "761118", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "761118", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "761118", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "761118", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "761118", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "761118", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "761118", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "761118", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "761118"}