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

020753

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 AROMASIN EXEMESTANE TABLET;ORAL 25MG Prescription AB ✓ ✓
Special Designations
Orphan (Sub 1)
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 25 AP 2024-12-16 LABELING STANDARD
SUPPL 22 AP 2021-11-17 LABELING STANDARD
SUPPL 20 AP 2018-05-18 LABELING STANDARD
SUPPL 18 AP 2016-07-25 EFFICACY STANDARD
SUPPL 17 AP 2014-07-28 MANUF (CMC) STANDARD
SUPPL 16 AP 2014-05-02 LABELING STANDARD
SUPPL 15 AP 2014-05-02 LABELING STANDARD
SUPPL 14 AP 2013-02-15 LABELING STANDARD
SUPPL 12 AP 2011-03-25 LABELING UNKNOWN
SUPPL 11 AP 2011-03-25 LABELING STANDARD
SUPPL 9 AP 2011-03-25 LABELING STANDARD
SUPPL 7 AP 2008-12-24 LABELING STANDARD
SUPPL 6 AP 2005-10-05 EFFICACY UNKNOWN
SUPPL 5 AP 2004-09-23 LABELING STANDARD
SUPPL 3 AP 2003-11-13 LABELING STANDARD
SUPPL 2 AP 2001-04-04 MANUF (CMC) STANDARD
SUPPL 1 AP 2001-04-04 MANUF (CMC) STANDARD
ORIG 1 AP 1999-10-21 TYPE 1 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2024-12-18 Letter SUPPL-25 0
2024-12-17 Label SUPPL-25 0
2021-11-18 Letter SUPPL-22 0
2021-11-18 Label SUPPL-22 0
2018-05-22 Label SUPPL-20 0
2018-05-21 Letter SUPPL-20 0
2016-07-27 Label SUPPL-18 0
2016-07-26 Letter SUPPL-18 0
2014-05-06 Letter SUPPL-16 0
2014-05-06 Label SUPPL-16 0
2014-05-06 Letter SUPPL-15 0
2014-05-06 Label SUPPL-15 0
2013-02-20 Letter SUPPL-14 0
2013-02-20 Label SUPPL-14 0
2011-03-28 Letter SUPPL-12 0
2011-03-28 Label SUPPL-9 0
2011-03-28 Label SUPPL-11 0
2011-03-28 Label SUPPL-12 0
2011-03-28 Letter SUPPL-9 0
2011-03-28 Letter SUPPL-11 0
2009-01-02 Patient Information Sheet SUPPL-7 0
2008-12-30 Letter SUPPL-7 0
2005-10-11 Letter SUPPL-6 0
2005-10-07 Label SUPPL-6 0
2004-09-29 Label SUPPL-5 0
2004-09-29 Letter SUPPL-5 0
2004-05-27 Review ORIG-1 0
2003-12-02 Label SUPPL-3 0
2003-11-25 Letter SUPPL-3 0
1999-10-21 Letter ORIG-1 0
1999-10-21 Label ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "8"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "28"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "28"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "25", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "20", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "15", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Orphan"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020753", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "020753", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "020753", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "020753", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 products INSERT {"ApplNo": "020753", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020753"}