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

210656

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 DAURISMO GLASDEGIB MALEATE TABLET;ORAL EQ 25MG BASE Prescription ✓
002 DAURISMO GLASDEGIB MALEATE TABLET;ORAL EQ 100MG BASE Prescription ✓ ✓
Special Designations
Orphan (Sub 1) Orphan (Sub 2) Orphan (Sub 4) Orphan (Sub 5)
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 5 AP 2023-03-27 LABELING STANDARD
SUPPL 2 AP 2020-03-19 LABELING STANDARD
SUPPL 4 AP 2020-03-19 LABELING STANDARD
ORIG 1 AP 2018-11-21 TYPE 1 PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2023-03-28 Letter SUPPL-5 0
2023-03-28 Label SUPPL-5 0
2023-03-28 Medication Guide SUPPL-5 0
2020-03-20 Label SUPPL-4 0
2020-03-20 Label SUPPL-2 0
2020-03-20 Letter SUPPL-4 0
2020-03-20 Letter SUPPL-2 0
2018-12-17 Review ORIG-1 0
2018-12-10 Letter ORIG-1 0
2018-11-21 Label ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "210656", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 submission_property_type INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Orphan"}
2026-07-12 submission_property_type INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Orphan"}
2026-07-12 submission_property_type INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Orphan"}
2026-07-12 submission_property_type INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "210656", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Orphan"}
2026-07-12 submission_property_type INSERT {"ApplNo": "210656", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "210656", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "210656", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "210656", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "210656", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "210656", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "210656", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "210656"}