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

020491

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CORVERT IBUTILIDE FUMARATE INJECTABLE;INJECTION 0.1MG/ML Prescription AP ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 9 AP 2014-06-09 MANUF (CMC) STANDARD
SUPPL 5 AP 2002-10-17 MANUF (CMC) STANDARD
SUPPL 3 AP 2001-04-20 LABELING STANDARD
SUPPL 4 AP 2000-04-03 MANUF (CMC) STANDARD
SUPPL 1 AP 1999-05-13 EFFICACY STANDARD
SUPPL 2 AP 1998-04-03 LABELING STANDARD
ORIG 1 AP 1995-12-28 TYPE 1 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2001-04-20 Letter SUPPL-3 0
2001-04-20 Label SUPPL-3 0
2001-04-20 Review SUPPL-3 0
1999-05-13 Letter SUPPL-1 0
1999-05-13 Review SUPPL-1 0
1999-05-13 Label SUPPL-1 0
1998-04-03 Review SUPPL-2 0
1996-03-16 Review ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020491", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "020491", "ProductNo": "001", "TECode": "AP"}
2026-07-12 marketing_status INSERT {"ApplNo": "020491", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "020491", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020491", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "020491", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020491"}