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

050551

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CEFOBID CEFOPERAZONE SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL Discontinued
002 CEFOBID CEFOPERAZONE SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL Discontinued
003 CEFOBID CEFOPERAZONE SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 48 AP 2025-03-03 LABELING STANDARD
SUPPL 47 AP 2024-12-17 LABELING STANDARD
SUPPL 46 AP 2020-09-18 LABELING STANDARD
SUPPL 44 AP 2018-06-18 LABELING STANDARD
SUPPL 45 AP 2017-09-28 LABELING STANDARD Please see <a href="https://www.fda.gov/STIC/">www.fda.gov/STIC</a> for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
SUPPL 43 AP 2015-03-18 LABELING STANDARD
SUPPL 42 AP 2002-12-18 LABELING STANDARD
SUPPL 41 AP 2001-12-07 MANUF (CMC) STANDARD
SUPPL 40 AP 1994-10-28 LABELING STANDARD
SUPPL 19 AP 1990-03-05 LABELING
SUPPL 38 AP 1988-09-29 LABELING
ORIG 1 AP 1982-11-18 TYPE 1 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2025-03-05 Label SUPPL-48 0
2025-03-04 Letter SUPPL-48 0
2024-12-18 Label SUPPL-47 0
2024-12-18 Letter SUPPL-47 0
2020-09-23 Letter SUPPL-46 0
2020-09-21 Label SUPPL-46 0
2018-06-21 Letter SUPPL-44 0
2018-06-21 Label SUPPL-44 0
2017-09-29 Label SUPPL-45 0
2017-09-29 Letter SUPPL-45 0
2015-03-19 Letter SUPPL-43 0
2015-03-19 Label SUPPL-43 0
2004-05-28 Letter SUPPL-42 0
2003-04-09 Label SUPPL-42 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "48", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050551", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "42", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "44", "ActionTypes_LookupID": "20"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "43", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "45", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "47", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "46", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "48", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "47", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "46", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "45", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "44", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "43", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "41", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "050551", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "050551", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "050551", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "050551", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 submissions INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "42"}
2026-07-12 submissions INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "43"}
2026-07-12 submissions INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "44"}
2026-07-12 submissions INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "45"}
2026-07-12 submissions INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "46"}
2026-07-12 submissions INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "47"}
2026-07-12 submissions INSERT {"ApplNo": "050551", "SubmissionType": "SUPPL", "SubmissionNo": "48"}
2026-07-12 products INSERT {"ApplNo": "050551", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "050551", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "050551", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "050551"}