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

050615

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CLEOCIN T CLINDAMYCIN PHOSPHATE GEL;TOPICAL EQ 1% BASE Prescription AB1 ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 21 AP 2025-11-12 LABELING STANDARD
SUPPL 19 AP 2019-12-16 LABELING STANDARD
SUPPL 18 AP 2019-04-19 LABELING STANDARD
SUPPL 16 AP 2017-11-16 LABELING STANDARD
SUPPL 14 AP 2016-01-15 LABELING STANDARD
SUPPL 13 AP 2015-01-12 MANUF (CMC) STANDARD
SUPPL 12 AP 2014-04-04 LABELING STANDARD
SUPPL 5 AP 2003-05-30 LABELING STANDARD
SUPPL 3 AP 2002-07-14 LABELING
SUPPL 4 AP 1998-01-27 MANUF (CMC) STANDARD
ORIG 1 AP 1987-01-07 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2025-11-13 Label SUPPL-21 0
2025-11-13 Letter SUPPL-21 0
2019-12-19 Letter SUPPL-19 0
2019-12-17 Label SUPPL-19 0
2019-05-15 Label SUPPL-18 0
2019-04-24 Letter SUPPL-18 0
2017-11-17 Label SUPPL-16 0
2017-11-17 Letter SUPPL-16 0
2016-01-26 Label SUPPL-14 0
2016-01-20 Letter SUPPL-14 0
2014-04-08 Label SUPPL-12 0
2014-04-07 Letter SUPPL-12 0
2003-06-08 Label SUPPL-5 0
2003-06-08 Letter SUPPL-5 0
2002-07-14 Letter SUPPL-3 0
2002-07-14 Label SUPPL-3 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050615", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "21", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "050615", "ProductNo": "001", "TECode": "AB1"}
2026-07-12 marketing_status INSERT {"ApplNo": "050615", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "050615", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "050615", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "050615", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "050615"}