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

050680

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CLEOCIN CLINDAMYCIN PHOSPHATE CREAM;VAGINAL EQ 2% BASE Discontinued
002 CLEOCIN CLINDAMYCIN PHOSPHATE CREAM;VAGINAL EQ 2% BASE Prescription AB ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 19 AP 2022-05-17 LABELING STANDARD
SUPPL 18 AP 2020-03-23 LABELING STANDARD
SUPPL 17 AP 2019-05-21 LABELING STANDARD
SUPPL 16 AP 2018-12-20 LABELING STANDARD
SUPPL 13 AP 2017-09-08 LABELING STANDARD
SUPPL 11 AP 2015-07-13 LABELING STANDARD
SUPPL 10 AP 2014-05-09 LABELING STANDARD
SUPPL 4 AP 2003-08-20 LABELING STANDARD
SUPPL 2 AP 1998-03-02 EFFICACY STANDARD
SUPPL 3 AP 1996-08-05 MANUF (CMC) STANDARD
SUPPL 1 AP 1995-10-05 EFFICACY UNKNOWN
ORIG 1 AP 1992-08-11 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2022-05-19 Label SUPPL-19 0
2022-05-18 Letter SUPPL-19 0
2020-03-24 Label SUPPL-18 0
2020-03-24 Letter SUPPL-18 0
2019-05-22 Letter SUPPL-17 0
2019-05-22 Label SUPPL-17 0
2018-12-21 Label SUPPL-16 0
2017-09-15 Letter SUPPL-13 0
2017-09-11 Label SUPPL-13 0
2015-07-16 Label SUPPL-11 0
2015-07-15 Letter SUPPL-11 0
2014-05-12 Letter SUPPL-10 0
2014-05-12 Label SUPPL-10 0
2003-08-29 Letter SUPPL-4 0
2003-08-29 Label SUPPL-4 0
1998-03-02 Letter SUPPL-2 0
1998-03-02 Review SUPPL-2 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "7"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "8"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "42"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "050680", "ProductNo": "002", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "050680", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "050680", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "050680", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "050680", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "050680", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "050680", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "050680"}