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

050441

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CLEOCIN PHOSPHATE CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 150MG BASE/ML Prescription AP ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 91 AP 2026-03-26 LABELING STANDARD
SUPPL 90 AP 2026-02-12 LABELING STANDARD
SUPPL 85 AP 2022-05-20 LABELING STANDARD
SUPPL 86 AP 2021-12-04 LABELING STANDARD
SUPPL 83 AP 2020-03-04 LABELING STANDARD
SUPPL 81 AP 2019-06-19 LABELING STANDARD
SUPPL 79 AP 2018-04-16 LABELING STANDARD
SUPPL 78 AP 2017-05-02 LABELING STANDARD Please see <a href="https://www.fda.gov/STIC/">www.fda.gov/STIC</a> for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
SUPPL 76 AP 2017-05-02 LABELING STANDARD
SUPPL 73 AP 2016-08-05 LABELING STANDARD
SUPPL 72 AP 2016-08-05 LABELING STANDARD
SUPPL 71 AP 2016-03-24 LABELING STANDARD
SUPPL 70 AP 2014-10-20 MANUF (CMC)
SUPPL 68 AP 2014-06-10 LABELING STANDARD
SUPPL 67 AP 2014-06-10 LABELING STANDARD
SUPPL 66 AP 2014-06-10 LABELING STANDARD
SUPPL 64 AP 2012-12-18 MANUF (CMC)
SUPPL 61 AP 2011-06-07 LABELING UNKNOWN
SUPPL 59 AP 2010-10-15 LABELING UNKNOWN
SUPPL 55 AP 2008-04-14 LABELING STANDARD
SUPPL 53 AP 2008-02-21 LABELING STANDARD
SUPPL 45 AP 2004-09-29 LABELING STANDARD
SUPPL 48 AP 2004-01-28 LABELING STANDARD
SUPPL 47 AP 2001-11-21 LABELING STANDARD
SUPPL 46 AP 2000-04-03 MANUF (CMC)
SUPPL 44 AP 1997-12-12 LABELING STANDARD
SUPPL 43 AP 1997-07-17 LABELING STANDARD
SUPPL 38 AP 1997-03-17 LABELING
SUPPL 25 AP 1997-03-17 LABELING
SUPPL 23 AP 1997-03-17 LABELING
SUPPL 40 AP 1996-03-05 LABELING
SUPPL 41 AP 1995-12-20 LABELING STANDARD
SUPPL 42 AP 1995-02-21 LABELING
SUPPL 37 AP 1993-03-23 MANUF (CMC)
SUPPL 35 AP 1991-06-11 LABELING
ORIG 1 AP 1972-10-02 UNKNOWN UNKNOWN
Documents (latest 100)
DateTypeSubmissionTitle / Link
2026-03-30 Label SUPPL-91 0
2026-03-30 Letter SUPPL-91 0
2026-02-18 Label SUPPL-90 0
2026-02-13 Letter SUPPL-90 0
2022-05-23 Letter SUPPL-85 0
2022-05-23 Label SUPPL-85 0
2021-12-07 Label SUPPL-86 0
2021-12-07 Letter SUPPL-86 0
2020-03-05 Letter SUPPL-83 0
2020-03-05 Label SUPPL-83 0
2019-06-20 Label SUPPL-81 0
2019-06-20 Letter SUPPL-81 0
2018-04-17 Label SUPPL-79 0
2018-04-17 Letter SUPPL-79 0
2017-05-08 Letter SUPPL-78 0
2017-05-08 Letter SUPPL-76 0
2017-05-04 Label SUPPL-76 0
2017-05-04 Label SUPPL-78 0
2016-08-05 Letter SUPPL-73 0
2016-08-05 Letter SUPPL-72 0
2016-08-05 Label SUPPL-72 0
2016-08-05 Label SUPPL-73 0
2016-03-29 Label SUPPL-71 0
2016-03-28 Letter SUPPL-71 0
2014-06-25 Label SUPPL-66 0
2014-06-25 Label SUPPL-67 0
2014-06-25 Label SUPPL-68 0
2014-06-12 Letter SUPPL-67 0
2014-06-12 Letter SUPPL-66 0
2014-06-12 Letter SUPPL-68 0
2011-06-10 Letter SUPPL-61 0
2010-10-20 Letter SUPPL-59 0
2008-04-23 Label SUPPL-55 0
2008-04-16 Letter SUPPL-55 0
2008-02-25 Letter SUPPL-53 0
2008-02-25 Label SUPPL-53 0
2004-10-04 Letter SUPPL-45 0
2004-10-04 Label SUPPL-45 0
2004-02-02 Letter SUPPL-48 0
2003-05-02 Label SUPPL-47 0
2001-11-21 Letter SUPPL-47 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "53", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "42", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "48", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "67", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "59", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "72", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "90", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "83", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "86", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "47", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "45", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "68", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "61", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "79", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "44", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "55", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "43", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "81", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "73", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "71", "ActionTypes_LookupID": "47"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "78", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "76", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "66", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "91", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "85", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "70", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "46", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "64", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "91", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "90", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "86", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "85", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "83", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "81", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "79", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "78", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "76", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "73", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "72", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "71", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "70", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "68", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "67", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "66", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "64", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "61", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "59", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "48", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "46", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "37", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "050441", "ProductNo": "001", "TECode": "AP"}
2026-07-12 marketing_status INSERT {"ApplNo": "050441", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "42"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "43"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "44"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "45"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "46"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "47"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "48"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "53"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "55"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "59"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "61"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "64"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "66"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "67"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "68"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "70"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "71"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "72"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "73"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "76"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "78"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "79"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "81"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "83"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "85"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "86"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "90"}
2026-07-12 submissions INSERT {"ApplNo": "050441", "SubmissionType": "SUPPL", "SubmissionNo": "91"}
2026-07-12 products INSERT {"ApplNo": "050441", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "050441"}