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

012616

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
004 ALDACTAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE TABLET;ORAL 25MG;25MG Prescription AB ✓
005 ALDACTAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE TABLET;ORAL 50MG;50MG Discontinued ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 85 AP 2025-11-14 LABELING STANDARD
SUPPL 83 AP 2022-12-19 LABELING STANDARD
SUPPL 81 AP 2021-02-19 LABELING STANDARD
SUPPL 80 AP 2020-08-20 LABELING STANDARD
SUPPL 78 AP 2019-01-17 LABELING STANDARD
SUPPL 76 AP 2014-10-22 LABELING STANDARD
SUPPL 75 AP 2014-03-06 LABELING STANDARD
SUPPL 74 AP 2014-01-17 LABELING STANDARD
SUPPL 72 AP 2013-06-14 MANUF (CMC)
SUPPL 73 AP 2013-06-12 LABELING STANDARD
SUPPL 69 AP 2011-09-22 LABELING UNKNOWN
SUPPL 68 AP 2011-05-19 LABELING UNKNOWN
SUPPL 63 AP 2002-11-26 MANUF (CMC)
SUPPL 62 AP 1999-04-21 LABELING STANDARD
SUPPL 61 AP 1999-01-13 LABELING STANDARD
SUPPL 58 AP 1997-11-13 LABELING
SUPPL 37 AP 1997-11-13 LABELING
SUPPL 55 AP 1990-01-23 MANUF (CMC)
SUPPL 16 AP 1978-01-04 REMS
ORIG 1 AP 1961-01-27 TYPE 4 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2025-11-18 Letter SUPPL-85 0
2025-11-17 Label SUPPL-85 0
2022-12-21 Label SUPPL-83 0
2022-12-21 Letter SUPPL-83 0
2021-02-23 Letter SUPPL-81 0
2021-02-22 Label SUPPL-81 0
2020-08-27 Label SUPPL-80 0
2020-08-24 Letter SUPPL-80 0
2019-01-18 Label SUPPL-78 0
2019-01-18 Letter SUPPL-78 0
2014-10-24 Label SUPPL-76 0
2014-03-07 Letter SUPPL-75 0
2014-03-07 Label SUPPL-75 0
2014-01-22 Label SUPPL-74 0
2014-01-21 Letter SUPPL-74 0
2013-06-18 Label SUPPL-73 0
2013-06-13 Letter SUPPL-73 0
2011-09-26 Letter SUPPL-69 0
2011-05-24 Letter SUPPL-68 0
2011-05-23 Label SUPPL-68 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "80", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "81", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "85", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "61", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "58", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "69", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "75", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "73", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "68", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "78", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "76", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "62", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "74", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "83", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "55", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "45"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "72", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "63", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "85", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "83", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "81", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "80", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "78", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "76", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "75", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "74", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "73", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "72", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "69", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "68", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "63", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "55", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "012616", "ProductNo": "004", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "012616", "ProductNo": "005"}
2026-07-12 marketing_status INSERT {"ApplNo": "012616", "ProductNo": "004"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "55"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "58"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "61"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "62"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "63"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "68"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "69"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "72"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "73"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "74"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "75"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "76"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "78"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "80"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "81"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "83"}
2026-07-12 submissions INSERT {"ApplNo": "012616", "SubmissionType": "SUPPL", "SubmissionNo": "85"}
2026-07-12 products INSERT {"ApplNo": "012616", "ProductNo": "005"}
2026-07-12 products INSERT {"ApplNo": "012616", "ProductNo": "004"}
2026-07-12 applications INSERT {"ApplNo": "012616"}