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

021212

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CAVERJECT IMPULSE ALPROSTADIL INJECTABLE;INJECTION 0.01MG/VIAL Prescription
002 CAVERJECT IMPULSE ALPROSTADIL INJECTABLE;INJECTION 0.02MG/VIAL Prescription
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 18 AP 2022-12-23 LABELING STANDARD
SUPPL 13 AP 2016-12-01 MANUF (CMC) STANDARD
SUPPL 15 AP 2016-10-25 LABELING STANDARD
SUPPL 16 AP 2016-10-25 LABELING STANDARD
SUPPL 14 AP 2016-05-05 LABELING STANDARD
SUPPL 11 AP 2015-10-27 LABELING STANDARD
SUPPL 12 AP 2015-01-12 MANUF (CMC) STANDARD
SUPPL 10 AP 2014-06-11 LABELING STANDARD
SUPPL 7 AP 2013-12-19 LABELING STANDARD
SUPPL 2 AP 2003-09-02 LABELING STANDARD
ORIG 1 AP 2002-06-11 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2022-12-27 Label SUPPL-18 0
2022-12-27 Letter SUPPL-18 0
2016-11-01 Label SUPPL-16 0
2016-11-01 Label SUPPL-15 0
2016-10-28 Letter SUPPL-15 0
2016-10-28 Letter SUPPL-16 0
2016-05-06 Letter SUPPL-14 0
2016-05-06 Label SUPPL-14 0
2015-11-04 Label SUPPL-11 0
2015-10-28 Letter SUPPL-11 0
2014-06-12 Letter SUPPL-10 0
2013-12-23 Label SUPPL-7 0
2013-12-20 Letter SUPPL-7 0
2003-09-09 Letter SUPPL-2 0
2002-06-11 Letter ORIG-1 0
2002-06-11 Review ORIG-1 0
2002-06-11 Label ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021212", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "15", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "021212", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "021212", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "021212", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "021212", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "021212", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "021212", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "021212"}