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

019885

NDA PFIZER PHARMS
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 ACCUPRIL QUINAPRIL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued AB ✓
002 ACCUPRIL QUINAPRIL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued AB ✓
003 ACCUPRIL QUINAPRIL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued AB ✓
004 ACCUPRIL QUINAPRIL HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued AB ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 45 AP 2020-05-18 LABELING STANDARD
SUPPL 43 AP 2017-04-26 LABELING STANDARD
SUPPL 42 AP 2017-02-13 LABELING STANDARD
SUPPL 41 AP 2015-09-11 LABELING STANDARD
SUPPL 40 AP 2014-05-02 LABELING STANDARD
SUPPL 39 AP 2013-10-25 LABELING STANDARD
SUPPL 38 AP 2013-09-23 LABELING STANDARD
SUPPL 37 AP 2013-04-09 LABELING STANDARD
SUPPL 36 AP 2012-09-21 LABELING UNKNOWN
SUPPL 35 AP 2012-01-18 LABELING UNKNOWN
SUPPL 33 AP 2011-10-14 LABELING UNKNOWN
SUPPL 28 AP 2009-09-18 LABELING STANDARD
SUPPL 23 AP 2003-10-29 LABELING STANDARD
SUPPL 22 AP 2002-12-13 MANUF (CMC) STANDARD
SUPPL 19 AP 2002-07-22 LABELING STANDARD
SUPPL 20 AP 2001-06-21 LABELING STANDARD
SUPPL 18 AP 2001-04-17 LABELING STANDARD
SUPPL 17 AP 1999-09-10 MANUF (CMC) STANDARD
SUPPL 16 AP 1998-05-04 MANUF (CMC) STANDARD
SUPPL 15 AP 1998-02-25 LABELING STANDARD
SUPPL 14 AP 1997-07-03 MANUF (CMC) STANDARD
SUPPL 13 AP 1997-07-02 MANUF (CMC) STANDARD
SUPPL 12 AP 1997-07-01 MANUF (CMC) STANDARD
SUPPL 11 AP 1996-07-03 LABELING STANDARD
SUPPL 10 AP 1996-06-18 MANUF (CMC) STANDARD
SUPPL 6 AP 1996-04-12 LABELING STANDARD
SUPPL 7 AP 1995-11-20 MANUF (CMC) STANDARD
SUPPL 9 AP 1995-11-02 MANUF (CMC) STANDARD
SUPPL 8 AP 1995-11-01 MANUF (CMC) STANDARD
SUPPL 3 AP 1994-10-12 LABELING STANDARD
SUPPL 1 AP 1993-10-29 EFFICACY
SUPPL 4 AP 1993-05-26 LABELING STANDARD
SUPPL 2 AP 1992-05-07 LABELING
ORIG 1 AP 1991-11-19 TYPE 1 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2025-10-20 Label SUPPL-45 0
2020-05-20 Letter SUPPL-45 0
2017-05-02 Letter SUPPL-43 0
2017-04-27 Label SUPPL-43 0
2017-02-15 Label SUPPL-42 0
2017-02-14 Letter SUPPL-42 0
2015-09-14 Letter SUPPL-41 0
2015-09-14 Label SUPPL-41 0
2014-05-06 Letter SUPPL-40 0
2014-05-06 Label SUPPL-40 0
2013-10-31 Label SUPPL-39 0
2013-10-28 Letter SUPPL-39 0
2013-09-24 Letter SUPPL-38 0
2013-09-23 Label SUPPL-38 0
2013-04-16 Label SUPPL-37 0
2013-04-11 Letter SUPPL-37 0
2012-09-25 Label SUPPL-36 0
2012-01-23 Letter SUPPL-35 0
2012-01-23 Label SUPPL-35 0
2011-10-20 Label SUPPL-33 0
2011-10-18 Letter SUPPL-33 0
2009-11-12 Letter SUPPL-28 0
2009-10-01 Label SUPPL-28 0
2006-06-09 Other Important Information from FDA ORIG-1 0
2003-11-05 Letter SUPPL-23 0
2003-07-30 Letter SUPPL-19 0
2001-04-17 Letter SUPPL-18 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "42", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "43", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "45", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "8"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "39", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "45", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "45", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "43", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "42", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "41", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "40", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "39", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "38", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "37", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "36", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "35", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "019885", "ProductNo": "004", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "019885", "ProductNo": "003", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "019885", "ProductNo": "002", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "019885", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "019885", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "019885", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "019885", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "019885", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "36"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "39"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "42"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "43"}
2026-07-12 submissions INSERT {"ApplNo": "019885", "SubmissionType": "SUPPL", "SubmissionNo": "45"}
2026-07-12 products INSERT {"ApplNo": "019885", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "019885", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "019885", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "019885", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "019885"}