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

019429

NDA ALLERGAN
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
003 FIORINAL W/CODEINE ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 45 AP 2021-04-28 LABELING STANDARD
SUPPL 44 AP 2021-04-28 LABELING STANDARD
SUPPL 43 AP 2019-10-07 LABELING STANDARD
SUPPL 42 AP 2018-09-18 LABELING STANDARD
SUPPL 41 AP 2018-09-18 REMS N/A
SUPPL 40 AP 2017-08-29 LABELING STANDARD
SUPPL 49 AP 2016-12-16 LABELING STANDARD
SUPPL 39 AP 2016-12-16 LABELING STANDARD
SUPPL 38 AP 2015-11-06 MANUF (CMC) STANDARD
SUPPL 37 AP 2014-11-16 MANUF (CMC) STANDARD
SUPPL 35 AP 2013-05-09 LABELING STANDARD
SUPPL 23 AP 2008-04-08 LABELING STANDARD
SUPPL 6 AP 2002-08-26 LABELING STANDARD
SUPPL 19 AP 2002-04-26 MANUF (CMC) STANDARD
SUPPL 16 AP 2001-10-04 LABELING STANDARD
SUPPL 18 AP 2001-06-28 MANUF (CMC) STANDARD
SUPPL 17 AP 2001-05-30 MANUF (CMC) STANDARD
SUPPL 15 AP 1999-11-10 MANUF (CMC) STANDARD
SUPPL 13 AP 1999-04-22 MANUF (CMC) STANDARD
SUPPL 11 AP 1996-07-12 MANUF (CMC) STANDARD
SUPPL 9 AP 1996-03-21 MANUF (CMC) STANDARD
SUPPL 10 AP 1995-11-20 MANUF (CMC) STANDARD
SUPPL 7 AP 1995-10-20 MANUF (CMC) STANDARD
SUPPL 5 AP 1994-04-05 MANUF (CMC) STANDARD
SUPPL 4 AP 1993-04-06 MANUF (CMC) STANDARD
SUPPL 3 AP 1993-04-06 MANUF (CMC) STANDARD
SUPPL 2 AP 1993-04-06 MANUF (CMC) STANDARD
SUPPL 1 AP 1991-04-29 LABELING
ORIG 1 AP 1990-10-26 TYPE 4 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2023-11-03 REMS ORIG-1 0
2021-05-03 Label SUPPL-45 0
2021-05-03 Label SUPPL-44 0
2021-05-03 Medication Guide SUPPL-45 0
2021-04-29 Letter SUPPL-44 0
2021-04-29 Letter SUPPL-45 0
2019-10-08 Label SUPPL-43 0
2019-10-08 Letter SUPPL-43 0
2018-10-05 Label SUPPL-41 0
2018-10-05 Label SUPPL-42 0
2018-09-28 Letter SUPPL-41 0
2018-09-28 Letter SUPPL-42 0
2017-08-30 Label SUPPL-40 0
2017-08-30 Letter SUPPL-40 0
2016-12-21 Label SUPPL-39 0
2016-12-20 Letter SUPPL-39 0
2013-05-14 Label SUPPL-35 0
2013-05-13 Letter SUPPL-35 0
2008-04-28 Label SUPPL-23 0
2008-04-28 Letter SUPPL-23 0
2008-04-28 Other SUPPL-23 Corrected Approval Letter
2002-08-26 Letter SUPPL-6 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "45", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "44", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "43", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "43", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "42", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "57"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "39", "ActionTypes_LookupID": "48"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "39", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "39", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "49", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "45", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "44", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "43", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "42", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "41", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "40", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "39", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "38", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "37", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "35", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "15", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "019429", "ProductNo": "003"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "39"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "42"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "43"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "44"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "45"}
2026-07-12 submissions INSERT {"ApplNo": "019429", "SubmissionType": "SUPPL", "SubmissionNo": "49"}
2026-07-12 products INSERT {"ApplNo": "019429", "ProductNo": "003"}
2026-07-12 applications INSERT {"ApplNo": "019429"}