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

010392

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 ATARAX HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
004 ATARAX HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
005 ATARAX HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
006 ATARAX HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 41 AP 2001-03-21 LABELING STANDARD
SUPPL 40 AP 2000-03-27 MANUF (CMC) STANDARD
SUPPL 38 AP 1998-01-16 MANUF (CMC) STANDARD
SUPPL 36 AP 1998-01-16 MANUF (CMC) STANDARD
SUPPL 37 AP 1994-07-12 MANUF (CMC) STANDARD
SUPPL 31 AP 1985-05-20 LABELING
SUPPL 21 AP 1979-05-21 LABELING
SUPPL 8 AP 1974-12-02 LABELING
ORIG 1 AP 1956-04-12 TYPE 1 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2001-03-21 Letter SUPPL-41 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010392", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "42"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "40", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "38", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "37", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "36", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "010392", "ProductNo": "006"}
2026-07-12 marketing_status INSERT {"ApplNo": "010392", "ProductNo": "005"}
2026-07-12 marketing_status INSERT {"ApplNo": "010392", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "010392", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "010392", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "36"}
2026-07-12 submissions INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "010392", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 products INSERT {"ApplNo": "010392", "ProductNo": "006"}
2026-07-12 products INSERT {"ApplNo": "010392", "ProductNo": "005"}
2026-07-12 products INSERT {"ApplNo": "010392", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "010392", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "010392"}