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

020379

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.01MG/VIAL Prescription AP ✓
002 CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.02MG/VIAL Prescription AP ✓ ✓
003 CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.005MG/VIAL Discontinued ✓
004 CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.04MG/VIAL Prescription AP ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 38 AP 2022-12-23 LABELING STANDARD
SUPPL 34 AP 2017-12-06 LABELING STANDARD
SUPPL 32 AP 2017-12-06 LABELING STANDARD
SUPPL 31 AP 2017-12-06 LABELING STANDARD
SUPPL 30 AP 2016-05-05 LABELING STANDARD
SUPPL 21 AP 2016-02-08 MANUF (CMC) PRIORITY
SUPPL 28 AP 2014-06-12 LABELING STANDARD
SUPPL 27 AP 2014-06-09 MANUF (CMC) PRIORITY
SUPPL 26 AP 2014-03-28 MANUF (CMC) PRIORITY
SUPPL 17 AP 2003-09-02 LABELING STANDARD
SUPPL 16 AP 2002-10-15 MANUF (CMC) PRIORITY
SUPPL 11 AP 2002-01-15 LABELING STANDARD
SUPPL 15 AP 2001-03-29 MANUF (CMC) PRIORITY
SUPPL 13 AP 2000-11-29 MANUF (CMC) PRIORITY
SUPPL 14 AP 2000-04-03 MANUF (CMC) PRIORITY
SUPPL 12 AP 1999-07-02 LABELING STANDARD
SUPPL 10 AP 1999-01-20 LABELING STANDARD
SUPPL 8 AP 1998-05-20 MANUF (CMC) PRIORITY
SUPPL 9 AP 1998-03-26 LABELING STANDARD
SUPPL 6 AP 1997-10-08 LABELING STANDARD
SUPPL 7 AP 1997-05-19 MANUF (CMC) PRIORITY
SUPPL 5 AP 1996-10-21 LABELING STANDARD
SUPPL 4 AP 1996-06-28 LABELING STANDARD
SUPPL 3 AP 1996-06-27 MANUF (CMC) PRIORITY
SUPPL 2 AP 1996-05-13 MANUF (CMC) PRIORITY
SUPPL 1 AP 1996-03-19 MANUF (CMC) PRIORITY
ORIG 1 AP 1995-07-06 TYPE 3 PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2022-12-27 Label SUPPL-38 0
2022-12-27 Letter SUPPL-38 0
2017-12-07 Letter SUPPL-31 0
2017-12-07 Letter SUPPL-32 0
2017-12-07 Letter SUPPL-34 0
2017-12-07 Label SUPPL-34 0
2017-12-07 Label SUPPL-31 0
2017-12-07 Label SUPPL-32 0
2016-05-06 Letter SUPPL-30 0
2016-05-06 Label SUPPL-30 0
2014-06-17 Letter SUPPL-28 0
2014-06-17 Label SUPPL-28 0
2003-09-09 Letter SUPPL-17 0
2002-01-15 Letter SUPPL-11 0
1998-03-26 Review SUPPL-9 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "48"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "34", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "38", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "34", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "32", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "31", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "26", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "21", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "15", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "020379", "ProductNo": "004", "TECode": "AP"}
2026-07-12 te INSERT {"ApplNo": "020379", "ProductNo": "002", "TECode": "AP"}
2026-07-12 te INSERT {"ApplNo": "020379", "ProductNo": "001", "TECode": "AP"}
2026-07-12 marketing_status INSERT {"ApplNo": "020379", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "020379", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "020379", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "020379", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "26"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "32"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "34"}
2026-07-12 submissions INSERT {"ApplNo": "020379", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 products INSERT {"ApplNo": "020379", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "020379", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "020379", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "020379", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020379"}