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

020125

NDA PFIZER PHARMS
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued AB ✓
002 ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued AB ✓
003 ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued AB ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 28 AP 2021-02-19 LABELING STANDARD
SUPPL 27 AP 2020-08-20 LABELING STANDARD
SUPPL 25 AP 2020-05-05 LABELING STANDARD
SUPPL 22 AP 2017-04-26 LABELING STANDARD
SUPPL 21 AP 2016-06-06 MANUF (CMC) STANDARD
SUPPL 20 AP 2015-09-11 LABELING STANDARD
SUPPL 19 AP 2015-02-05 LABELING STANDARD
SUPPL 18 AP 2014-05-02 LABELING STANDARD
SUPPL 16 AP 2014-01-17 LABELING STANDARD
SUPPL 17 AP 2013-10-25 LABELING STANDARD
SUPPL 15 AP 2013-09-23 LABELING STANDARD
SUPPL 13 AP 2012-12-19 MANUF (CMC) STANDARD
SUPPL 14 AP 2012-09-21 LABELING STANDARD
SUPPL 12 AP 2012-01-18 LABELING UNKNOWN
SUPPL 11 AP 2011-10-14 LABELING UNKNOWN
SUPPL 10 AP 2011-03-20 LABELING UNKNOWN
SUPPL 7 AP 2009-09-18 LABELING STANDARD
SUPPL 3 AP 2003-10-29 LABELING STANDARD
SUPPL 1 AP 2002-01-28 MANUF (CMC) STANDARD
ORIG 1 AP 1999-12-28 TYPE 4 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2021-03-18 Letter SUPPL-28 0
2021-02-22 Label SUPPL-28 0
2020-08-27 Label SUPPL-27 0
2020-08-21 Letter SUPPL-27 0
2020-05-06 Label SUPPL-25 0
2020-05-06 Letter SUPPL-25 0
2017-05-02 Letter SUPPL-22 0
2017-04-27 Label SUPPL-22 0
2015-09-14 Label SUPPL-20 0
2015-02-06 Letter SUPPL-19 0
2015-02-06 Label SUPPL-19 0
2014-05-06 Label SUPPL-18 0
2014-05-06 Letter SUPPL-18 0
2014-01-22 Label SUPPL-16 0
2014-01-21 Letter SUPPL-16 0
2013-10-31 Label SUPPL-17 0
2013-10-28 Letter SUPPL-17 0
2013-09-24 Letter SUPPL-15 0
2013-09-23 Label SUPPL-15 0
2012-09-25 Label SUPPL-14 0
2012-09-24 Letter SUPPL-14 0
2012-01-23 Letter SUPPL-12 0
2012-01-23 Label SUPPL-12 0
2011-10-20 Label SUPPL-11 0
2011-10-18 Letter SUPPL-11 0
2011-03-24 Letter SUPPL-10 0
2011-03-22 Label SUPPL-10 0
2009-11-12 Letter SUPPL-7 0
2009-10-01 Label SUPPL-7 0
2003-11-05 Letter SUPPL-3 0
2001-05-31 Review ORIG-1 0
1999-12-28 Letter ORIG-1 0
1999-12-28 Label ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "25", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "21", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "20", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "15", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "020125", "ProductNo": "003", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "020125", "ProductNo": "002", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "020125", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "020125", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "020125", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "020125", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020125", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "020125", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "020125", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "020125", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020125"}