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

213871

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CIBINQO ABROCITINIB TABLET;ORAL 50MG Prescription ✓
002 CIBINQO ABROCITINIB TABLET;ORAL 100MG Prescription ✓
003 CIBINQO ABROCITINIB TABLET;ORAL 200MG Prescription ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 5 AP 2026-06-30 LABELING STANDARD
SUPPL 4 AP 2023-12-14 EFFICACY STANDARD
SUPPL 1 AP 2023-02-09 EFFICACY PRIORITY
ORIG 1 AP 2022-01-14 TYPE 1 PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2026-07-02 Letter SUPPL-5 0
2023-12-15 Label SUPPL-4 0
2023-12-15 Medication Guide SUPPL-4 0
2023-12-15 Letter SUPPL-4 0
2023-02-10 Label SUPPL-1 0
2023-02-10 Letter SUPPL-1 0
2022-02-10 Review ORIG-1 0
2022-01-19 Letter ORIG-1 0
2022-01-19 Label ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "213871", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "213871", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "213871", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "213871", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 submission_property_type INSERT {"ApplNo": "213871", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "213871", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "213871", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "213871", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "213871", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "213871", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "213871", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "213871", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "213871", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "213871", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "213871", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "213871", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "213871", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "213871", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "213871"}