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

011757

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 DEPO-MEDROL METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Prescription AB ✓
002 DEPO-MEDROL METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 20MG/ML Prescription AB ✓ ✓
004 DEPO-MEDROL METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Prescription AB ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 124 AP 2025-11-04 LABELING STANDARD
SUPPL 125 AP 2024-06-05 LABELING STANDARD
SUPPL 123 AP 2023-12-20 LABELING STANDARD
SUPPL 120 AP 2021-05-27 LABELING STANDARD
SUPPL 119 AP 2021-02-11 LABELING STANDARD
SUPPL 114 AP 2018-07-24 LABELING STANDARD
SUPPL 111 AP 2017-03-15 LABELING STANDARD
SUPPL 104 AP 2016-09-08 LABELING STANDARD
SUPPL 103 AP 2014-07-03 LABELING STANDARD
SUPPL 102 AP 2014-06-09 MANUF (CMC) STANDARD
SUPPL 98 AP 2013-10-11 MANUF (CMC) STANDARD
SUPPL 97 AP 2013-10-07 MANUF (CMC) STANDARD
SUPPL 86 AP 2009-04-07 LABELING STANDARD
SUPPL 85 AP 2009-04-07 LABELING STANDARD
SUPPL 79 AP 2002-05-22 MANUF (CMC) STANDARD
SUPPL 78 AP 2000-04-04 MANUF (CMC) STANDARD
SUPPL 75 AP 1995-01-24 MANUF (CMC) STANDARD
SUPPL 72 AP 1994-01-07 MANUF (CMC) STANDARD
SUPPL 70 AP 1993-12-28 MANUF (CMC) STANDARD
SUPPL 64 AP 1990-11-15 MANUF (CMC) STANDARD
SUPPL 63 AP 1989-12-14 LABELING
SUPPL 59 AP 1989-01-05 MANUF (CMC) STANDARD
SUPPL 60 AP 1986-05-12 LABELING
SUPPL 55 AP 1986-05-12 LABELING
SUPPL 53 AP 1986-05-12 LABELING
SUPPL 58 AP 1983-03-09 LABELING
SUPPL 57 AP 1983-03-09 LABELING
SUPPL 50 AP 1981-02-17 MANUF (CMC) STANDARD
SUPPL 54 AP 1980-07-29 MANUF (CMC) STANDARD
SUPPL 52 AP 1978-07-12 LABELING
ORIG 1 AP 1959-05-27 TYPE 2 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2025-11-07 Label SUPPL-124 0
2025-11-05 Letter SUPPL-124 0
2024-06-07 Letter SUPPL-125 0
2024-06-06 Label SUPPL-125 0
2023-12-22 Letter SUPPL-123 0
2023-12-21 Label SUPPL-123 0
2021-06-04 Label SUPPL-120 0
2021-05-28 Letter SUPPL-120 0
2021-02-16 Letter SUPPL-119 0
2021-02-16 Label SUPPL-119 0
2020-07-29 Label SUPPL-111 0
2018-07-26 Letter SUPPL-114 0
2018-07-25 Label SUPPL-114 0
2017-03-20 Letter SUPPL-111 0
2016-09-09 Letter SUPPL-104 0
2016-09-09 Label SUPPL-104 0
2014-07-09 Label SUPPL-103 0
2014-07-08 Letter SUPPL-103 0
2009-04-16 Label SUPPL-85 0
2009-04-16 Letter SUPPL-85 0
2009-04-16 Letter SUPPL-86 0
2009-04-16 Label SUPPL-86 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "53", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "120", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "63", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "111", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "119", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "124", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "86", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "103", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "52", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "58", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "104", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "85", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "114", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "60", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "55", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "125", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "57", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "123", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "59", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "64", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "102", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "97", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "79", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "75", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "54", "ActionTypes_LookupID": "34"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "70", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "78", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "50", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "72", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "98", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "125", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "124", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "123", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "120", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "119", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "114", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "111", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "104", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "103", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "102", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "98", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "97", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "79", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "78", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "75", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "72", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "70", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "64", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "59", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "54", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "50", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "011757", "ProductNo": "004", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "011757", "ProductNo": "002", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "011757", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "011757", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "011757", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "011757", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "50"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "52"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "53"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "54"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "55"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "57"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "58"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "59"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "60"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "63"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "64"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "70"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "72"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "75"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "78"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "79"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "85"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "86"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "97"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "98"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "102"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "103"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "104"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "111"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "114"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "119"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "120"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "123"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "124"}
2026-07-12 submissions INSERT {"ApplNo": "011757", "SubmissionType": "SUPPL", "SubmissionNo": "125"}
2026-07-12 products INSERT {"ApplNo": "011757", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "011757", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "011757", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "011757"}