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

020222

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 COLESTID COLESTIPOL HYDROCHLORIDE TABLET;ORAL 1GM Prescription AB ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 6 AP 2017-05-25 LABELING STANDARD
SUPPL 5 AP 2014-05-22 LABELING STANDARD
SUPPL 2 AP 2002-04-12 MANUF (CMC) PRIORITY
SUPPL 1 AP 1995-09-22 LABELING STANDARD
ORIG 1 AP 1994-07-19 TYPE 3 PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2024-09-06 Label SUPPL-6 0
2017-05-26 Letter SUPPL-6 0
2014-05-28 Label SUPPL-5 0
2014-05-23 Letter SUPPL-5 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020222", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020222", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020222", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020222", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020222", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020222", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020222", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020222", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020222", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "020222", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "020222", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020222", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020222", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020222", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "020222", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "020222", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 products INSERT {"ApplNo": "020222", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020222"}