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

050613

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CEFOBID IN PLASTIC CONTAINER CEFOPERAZONE SODIUM INJECTABLE;INJECTION EQ 40MG BASE/ML Discontinued
002 CEFOBID IN PLASTIC CONTAINER CEFOPERAZONE SODIUM INJECTABLE;INJECTION EQ 20MG BASE/ML Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 8 AP 1998-06-01 MANUF (CMC) STANDARD
SUPPL 6 AP 1996-12-03 MANUF (CMC) STANDARD
SUPPL 7 AP 1994-10-28 LABELING STANDARD
SUPPL 5 AP 1989-08-01 MANUF (CMC) STANDARD
SUPPL 1 AP 1988-09-29 LABELING
SUPPL 2 AP 1988-07-20 LABELING
SUPPL 4 AP 1987-11-10 MANUF (CMC) STANDARD
SUPPL 3 AP 1987-07-31 MANUF (CMC) STANDARD
ORIG 1 AP 1986-07-23 TYPE 3 STANDARD
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050613", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "34"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "050613", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "050613", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "050613", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "050613", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "050613", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "050613", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "050613"}