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

062644

ANDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CLEOCIN CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR SOLUTION;ORAL EQ 75MG BASE/5ML Prescription AA ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 32 AP 2026-05-21 LABELING STANDARD
SUPPL 34 AP 2026-05-21 LABELING STANDARD
SUPPL 35 AP 2026-05-21 LABELING STANDARD
SUPPL 31 AP 2020-04-14 LABELING STANDARD
SUPPL 28 AP 2019-10-22 LABELING STANDARD
SUPPL 29 AP 2019-10-22 LABELING STANDARD
SUPPL 27 AP 2017-08-16 LABELING STANDARD
SUPPL 19 AP 2016-11-07 LABELING
SUPPL 24 AP 2016-11-07 LABELING STANDARD
SUPPL 25 AP 2016-11-07 LABELING STANDARD
SUPPL 9 AP 2014-12-11 LABELING
SUPPL 21 AP 2014-09-25 LABELING STANDARD
SUPPL 22 AP 2014-09-25 LABELING STANDARD
SUPPL 15 AP 2007-11-21 LABELING
SUPPL 5 AP 1992-09-29 MANUF (CMC)
ORIG 1 AP 1986-04-07
Documents (latest 100)
DateTypeSubmissionTitle / Link
2012-11-27 Label SUPPL-15 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "29", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "34", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "35", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "34", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "32", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "31", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "29", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "25", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "24", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "21", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "062644", "ProductNo": "001", "TECode": "AA"}
2026-07-12 marketing_status INSERT {"ApplNo": "062644", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "34"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "32"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "29"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "062644", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "062644", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "062644"}