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

017563

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 FLAVORED COLESTID COLESTIPOL HYDROCHLORIDE GRANULE;ORAL 5GM/PACKET Discontinued ✓
002 FLAVORED COLESTID COLESTIPOL HYDROCHLORIDE GRANULE;ORAL 5GM/SCOOPFUL Discontinued ✓
003 COLESTID COLESTIPOL HYDROCHLORIDE GRANULE;ORAL 5GM/SCOOPFUL Prescription AB ✓
004 COLESTID COLESTIPOL HYDROCHLORIDE GRANULE;ORAL 5GM/PACKET Prescription AB ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 24 AP 2018-04-25 LABELING STANDARD
SUPPL 23 AP 2014-05-22 LABELING STANDARD
SUPPL 19 AP 1996-03-26 MANUF (CMC) PRIORITY
SUPPL 20 AP 1996-01-18 MANUF (CMC) PRIORITY
SUPPL 21 AP 1995-09-22 LABELING STANDARD
SUPPL 13 AP 1993-12-06 MANUF (CMC) PRIORITY
SUPPL 15 AP 1992-06-01 MANUF (CMC) PRIORITY
SUPPL 17 AP 1992-04-09 LABELING
SUPPL 16 AP 1991-12-18 LABELING
SUPPL 12 AP 1991-08-06 LABELING
SUPPL 14 AP 1991-06-17 LABELING
SUPPL 11 AP 1990-07-27 LABELING
SUPPL 10 AP 1987-04-03 MANUF (CMC) PRIORITY
SUPPL 9 AP 1986-11-24 LABELING
SUPPL 7 AP 1985-02-25 MANUF (CMC) PRIORITY
SUPPL 4 AP 1982-02-19 LABELING
SUPPL 5 AP 1982-02-19 LABELING
SUPPL 6 AP 1982-02-19 LABELING
SUPPL 2 AP 1979-07-23 MANUF (CMC) PRIORITY
SUPPL 3 AP 1979-04-17 LABELING
SUPPL 1 AP 1977-05-16 MANUF (CMC) PRIORITY
ORIG 1 AP 1977-04-04 TYPE 1 PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2018-04-27 Letter SUPPL-24 0
2014-05-28 Label SUPPL-23 0
2014-05-23 Letter SUPPL-23 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "34"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "37"}
2026-07-12 submission_property_type INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "24", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "23", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "20", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "15", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "017563", "ProductNo": "004", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "017563", "ProductNo": "003", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "017563", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "017563", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "017563", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "017563", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "017563", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "017563", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "017563", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "017563", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "017563", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "017563"}