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

050639

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
002 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
003 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 45 AP 2026-03-26 LABELING STANDARD
SUPPL 44 AP 2026-02-12 LABELING STANDARD
SUPPL 42 AP 2022-05-20 LABELING STANDARD
SUPPL 43 AP 2021-12-04 LABELING STANDARD
SUPPL 41 AP 2020-03-04 LABELING STANDARD
SUPPL 40 AP 2019-06-19 LABELING STANDARD
SUPPL 38 AP 2018-04-16 LABELING STANDARD
SUPPL 37 AP 2017-05-02 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 35 AP 2017-05-02 LABELING STANDARD
SUPPL 34 AP 2016-08-05 LABELING STANDARD
SUPPL 33 AP 2016-08-05 LABELING STANDARD
SUPPL 32 AP 2016-05-20 MANUF (CMC) STANDARD
SUPPL 31 AP 2016-03-24 LABELING STANDARD
SUPPL 30 AP 2014-09-18 MANUF (CMC) STANDARD
SUPPL 29 AP 2014-06-25 LABELING STANDARD
SUPPL 28 AP 2014-06-25 LABELING STANDARD
SUPPL 27 AP 2014-06-25 LABELING STANDARD
SUPPL 26 AP 2013-10-09 MANUF (CMC) STANDARD
SUPPL 25 AP 2013-06-26 MANUF (CMC) STANDARD
SUPPL 22 AP 2011-06-07 LABELING UNKNOWN
SUPPL 16 AP 2008-04-14 LABELING STANDARD
SUPPL 15 AP 2008-02-21 LABELING STANDARD
SUPPL 13 AP 2004-09-29 LABELING STANDARD
SUPPL 14 AP 2004-01-28 LABELING STANDARD
SUPPL 10 AP 1998-03-09 MANUF (CMC) STANDARD
SUPPL 12 AP 1997-12-12 LABELING STANDARD
SUPPL 11 AP 1997-07-17 LABELING STANDARD
SUPPL 5 AP 1997-03-17 LABELING
SUPPL 7 AP 1995-12-20 LABELING STANDARD
SUPPL 9 AP 1995-02-21 LABELING STANDARD
SUPPL 8 AP 1993-04-05 MANUF (CMC) STANDARD
SUPPL 4 AP 1992-05-21 MANUF (CMC) STANDARD
SUPPL 2 AP 1991-06-11 LABELING
SUPPL 1 AP 1991-04-18 MANUF (CMC) STANDARD
SUPPL 3 AP 1991-04-10 MANUF (CMC) STANDARD
ORIG 1 AP 1989-08-30 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2026-03-30 Label SUPPL-45 0
2026-03-30 Letter SUPPL-45 0
2026-02-18 Label SUPPL-44 0
2026-02-13 Letter SUPPL-44 0
2022-05-23 Letter SUPPL-42 0
2022-05-23 Label SUPPL-42 0
2021-12-07 Label SUPPL-43 0
2021-12-07 Letter SUPPL-43 0
2020-03-05 Letter SUPPL-41 0
2020-03-05 Label SUPPL-41 0
2019-06-20 Label SUPPL-40 0
2019-06-20 Letter SUPPL-40 0
2018-04-17 Label SUPPL-38 0
2018-04-17 Letter SUPPL-38 0
2017-05-08 Letter SUPPL-37 0
2017-05-08 Letter SUPPL-35 0
2017-05-05 Label SUPPL-37 0
2017-05-05 Label SUPPL-35 0
2016-08-05 Letter SUPPL-33 0
2016-08-05 Letter SUPPL-34 0
2016-08-05 Label SUPPL-34 0
2016-08-05 Label SUPPL-33 0
2016-03-29 Label SUPPL-31 0
2016-03-28 Letter SUPPL-31 0
2014-07-03 Label SUPPL-27 0
2014-07-03 Label SUPPL-29 0
2014-07-03 Label SUPPL-28 0
2014-06-27 Letter SUPPL-27 0
2014-06-27 Letter SUPPL-28 0
2014-06-27 Letter SUPPL-29 0
2011-06-10 Letter SUPPL-22 0
2008-04-23 Label SUPPL-16 0
2008-04-16 Letter SUPPL-16 0
2008-02-25 Label SUPPL-15 0
2008-02-25 Letter SUPPL-15 0
2004-10-04 Letter SUPPL-13 0
2004-10-04 Label SUPPL-13 0
2004-02-02 Letter SUPPL-14 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "34", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "29", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "43", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "44", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "45", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "47"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "42", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "45", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "44", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "43", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "42", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "41", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "40", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "38", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "37", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "35", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "34", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "32", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "31", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "29", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "26", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "25", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "050639", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "050639", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "050639", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "26"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "29"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "32"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "34"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "42"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "43"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "44"}
2026-07-12 submissions INSERT {"ApplNo": "050639", "SubmissionType": "SUPPL", "SubmissionNo": "45"}
2026-07-12 products INSERT {"ApplNo": "050639", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "050639", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "050639", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "050639"}