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

012151

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
008 ALDACTONE SPIRONOLACTONE TABLET;ORAL 50MG Prescription AB ✓
009 ALDACTONE SPIRONOLACTONE TABLET;ORAL 25MG Prescription AB ✓
010 ALDACTONE SPIRONOLACTONE TABLET;ORAL 100MG Prescription AB ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 80 AP 2025-11-14 LABELING STANDARD
SUPPL 79 AP 2022-12-19 LABELING STANDARD
SUPPL 77 AP 2020-07-28 LABELING STANDARD
SUPPL 75 AP 2018-03-06 LABELING STANDARD
SUPPL 74 AP 2016-04-11 MANUF (CMC) PRIORITY
SUPPL 73 AP 2015-05-01 MANUF (CMC) PRIORITY
SUPPL 72 AP 2014-10-22 LABELING STANDARD
SUPPL 71 AP 2013-06-12 LABELING STANDARD
SUPPL 68 AP 2012-09-17 LABELING UNKNOWN
SUPPL 67 AP 2011-09-22 LABELING UNKNOWN
SUPPL 62 AP 2008-11-25 LABELING STANDARD
SUPPL 61 AP 2002-11-26 MANUF (CMC) PRIORITY
SUPPL 60 AP 1999-03-26 LABELING STANDARD
SUPPL 59 AP 1999-01-13 LABELING STANDARD
SUPPL 56 AP 1997-07-30 LABELING
SUPPL 35 AP 1997-07-30 LABELING
SUPPL 58 AP 1996-05-14 MANUF (CMC) PRIORITY
SUPPL 57 AP 1995-05-31 MANUF (CMC) PRIORITY
SUPPL 55 AP 1992-05-07 LABELING
SUPPL 53 AP 1990-03-15 LABELING
SUPPL 54 AP 1990-01-23 MANUF (CMC) PRIORITY
SUPPL 52 AP 1989-10-30 LABELING
SUPPL 50 AP 1988-11-09 LABELING
SUPPL 48 AP 1987-11-23 MANUF (CMC) PRIORITY
SUPPL 49 AP 1987-06-15 MANUF (CMC) PRIORITY
SUPPL 47 AP 1986-01-13 LABELING
SUPPL 46 AP 1985-09-26 LABELING
SUPPL 45 AP 1985-08-15 MANUF (CMC) PRIORITY
SUPPL 44 AP 1984-11-05 LABELING
SUPPL 43 AP 1984-03-22 LABELING
SUPPL 42 AP 1983-12-20 LABELING
SUPPL 36 AP 1983-11-29 MANUF (CMC) PRIORITY
SUPPL 33 AP 1983-11-29 MANUF (CMC) PRIORITY
SUPPL 41 AP 1983-07-29 LABELING
SUPPL 40 AP 1983-04-07 MANUF (CMC) PRIORITY
SUPPL 38 AP 1982-12-30 MANUF (CMC) PRIORITY
SUPPL 37 AP 1982-05-03 LABELING
SUPPL 30 AP 1981-06-30 EFFICACY
SUPPL 34 AP 1981-06-22 MANUF (CMC) PRIORITY
SUPPL 31 AP 1981-03-04 MANUF (CMC) PRIORITY
SUPPL 22 AP 1976-11-10 LABELING
ORIG 1 AP 1960-01-21 TYPE 1 PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2025-11-18 Letter SUPPL-80 0
2025-11-17 Label SUPPL-80 0
2022-12-21 Label SUPPL-79 0
2022-12-21 Letter SUPPL-79 0
2020-07-30 Label SUPPL-77 0
2020-07-29 Letter SUPPL-77 0
2018-03-12 Letter SUPPL-75 0
2018-03-08 Label SUPPL-75 0
2014-10-24 Label SUPPL-72 0
2013-06-18 Label SUPPL-71 0
2013-06-13 Letter SUPPL-71 0
2012-09-20 Letter SUPPL-68 0
2012-09-17 Label SUPPL-68 0
2011-09-26 Letter SUPPL-67 0
2009-01-02 Label SUPPL-62 0
2008-11-26 Letter SUPPL-62 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "67", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "77", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "68", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "55", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "46", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "80", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "59", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "60", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "56", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "43", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "79", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "44", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "72", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "52", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "47", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "2"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "71", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "50", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "53", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "62", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "75", "ActionTypes_LookupID": "48"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "42", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "58", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "49", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "57", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "48", "ActionTypes_LookupID": "34"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "45", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "74", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "34", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "73", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "54", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "61", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "42"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "80", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "79", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "77", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "75", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "74", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "73", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "72", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "71", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "68", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "67", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "61", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "58", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "57", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "54", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "49", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "48", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "45", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "40", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "38", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "36", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "34", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "31", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "012151", "ProductNo": "010", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "012151", "ProductNo": "009", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "012151", "ProductNo": "008", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "012151", "ProductNo": "010"}
2026-07-12 marketing_status INSERT {"ApplNo": "012151", "ProductNo": "009"}
2026-07-12 marketing_status INSERT {"ApplNo": "012151", "ProductNo": "008"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "34"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "36"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "42"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "43"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "44"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "45"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "46"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "47"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "48"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "49"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "50"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "52"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "53"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "54"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "55"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "56"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "57"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "58"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "59"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "60"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "61"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "62"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "67"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "68"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "71"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "72"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "73"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "74"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "75"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "77"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "79"}
2026-07-12 submissions INSERT {"ApplNo": "012151", "SubmissionType": "SUPPL", "SubmissionNo": "80"}
2026-07-12 products INSERT {"ApplNo": "012151", "ProductNo": "010"}
2026-07-12 products INSERT {"ApplNo": "012151", "ProductNo": "009"}
2026-07-12 products INSERT {"ApplNo": "012151", "ProductNo": "008"}
2026-07-12 applications INSERT {"ApplNo": "012151"}