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

050600

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CLEOCIN T CLINDAMYCIN PHOSPHATE LOTION;TOPICAL EQ 1% BASE Prescription AB ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 20 AP 2025-11-12 LABELING STANDARD
SUPPL 18 AP 2019-12-16 LABELING STANDARD
SUPPL 17 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 2014-04-04 LABELING STANDARD
SUPPL 7 AP 2003-05-30 LABELING STANDARD
SUPPL 2 AP 2002-07-14 LABELING
SUPPL 6 AP 1994-09-05 MANUF (CMC) STANDARD
SUPPL 5 AP 1993-10-20 MANUF (CMC) STANDARD
SUPPL 1 AP 1993-04-07 MANUF (CMC) STANDARD
SUPPL 3 AP 1991-09-23 MANUF (CMC) STANDARD
ORIG 1 AP 1989-05-31 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2025-11-13 Label SUPPL-20 0
2025-11-13 Letter SUPPL-20 0
2019-12-19 Letter SUPPL-18 0
2019-12-17 Label SUPPL-18 0
2019-05-15 Label SUPPL-17 0
2019-04-24 Letter SUPPL-17 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-13 0
2014-04-07 Letter SUPPL-13 0
2003-06-08 Letter SUPPL-7 0
2003-06-08 Label SUPPL-7 0
2002-07-14 Label SUPPL-2 0
2002-07-14 Letter SUPPL-2 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "37"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "20", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "050600", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "050600", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "050600", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 products INSERT {"ApplNo": "050600", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "050600"}