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

050537

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CLEOCIN T CLINDAMYCIN PHOSPHATE SOLUTION;TOPICAL EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
002 CLEOCIN CLINDAMYCIN PHOSPHATE SWAB;TOPICAL EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 42 AP 2025-11-12 LABELING STANDARD
SUPPL 41 AP 2019-12-16 LABELING STANDARD
SUPPL 40 AP 2019-04-19 LABELING STANDARD
SUPPL 39 AP 2017-11-16 LABELING STANDARD
SUPPL 37 AP 2016-01-15 LABELING STANDARD
SUPPL 36 AP 2014-08-29 MANUF (CMC) STANDARD
SUPPL 35 AP 2014-04-04 LABELING STANDARD
SUPPL 26 AP 2003-05-30 LABELING STANDARD
SUPPL 13 AP 2002-07-14 LABELING
SUPPL 24 AP 1999-06-07 MANUF (CMC) STANDARD
SUPPL 23 AP 1994-09-05 MANUF (CMC) STANDARD
SUPPL 14 AP 1994-02-22 MANUF (CMC) STANDARD
SUPPL 16 AP 1992-12-21 MANUF (CMC) STANDARD
SUPPL 11 AP 1989-07-28 MANUF (CMC) STANDARD
SUPPL 10 AP 1989-03-15 LABELING
SUPPL 5 AP 1986-07-18 LABELING
SUPPL 7 AP 1986-01-23 MANUF (CMC) STANDARD
SUPPL 6 AP 1984-08-06 LABELING
SUPPL 4 AP 1983-03-02 LABELING
SUPPL 21 AP 1982-02-25 LABELING
SUPPL 19 AP 1981-11-23 LABELING
SUPPL 18 AP 1981-11-18 LABELING
SUPPL 22 AP 1981-08-21 MANUF (CMC) STANDARD
SUPPL 8 AP 1981-05-11 LABELING
SUPPL 9 AP 1981-04-20 LABELING
SUPPL 3 AP 1980-09-30 MANUF (CMC) STANDARD
SUPPL 2 AP 1980-09-15 MANUF (CMC) STANDARD
SUPPL 1 AP 1980-08-14 LABELING
ORIG 1 AP 1980-07-09 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2025-11-13 Label SUPPL-42 0
2025-11-13 Letter SUPPL-42 0
2019-12-19 Letter SUPPL-41 0
2019-12-17 Label SUPPL-41 0
2019-05-15 Label SUPPL-40 0
2019-04-24 Letter SUPPL-40 0
2017-11-17 Label SUPPL-39 0
2017-11-17 Letter SUPPL-39 0
2016-01-26 Label SUPPL-37 0
2016-01-20 Letter SUPPL-37 0
2014-04-08 Label SUPPL-35 0
2014-04-07 Letter SUPPL-35 0
2003-06-08 Letter SUPPL-26 0
2003-06-08 Label SUPPL-26 0
2002-07-14 Label SUPPL-13 0
2002-07-14 Letter SUPPL-13 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "39", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "42", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "34"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "42", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "41", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "40", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "39", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "37", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "36", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "35", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "24", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "23", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "050537", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "050537", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "26"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "36"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "39"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 submissions INSERT {"ApplNo": "050537", "SubmissionType": "SUPPL", "SubmissionNo": "42"}
2026-07-12 products INSERT {"ApplNo": "050537", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "050537", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "050537"}