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

074951

ANDA STEVENS J
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG Prescription AB ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 13 AP 2026-06-18 REMS
SUPPL 11 AP 2025-12-22 LABELING STANDARD
SUPPL 10 AP 2024-11-21 LABELING STANDARD
SUPPL 9 AP 2024-10-31 REMS
SUPPL 8 AP 2024-10-09 LABELING STANDARD
SUPPL 7 AP 2023-12-15 LABELING STANDARD
SUPPL 5 AP 2023-12-11 LABELING STANDARD
SUPPL 4 AP 2018-09-18 REMS
SUPPL 2 AP 2007-11-09 LABELING
ORIG 1 AP 1998-08-31
Documents (latest 100)
DateTypeSubmissionTitle / Link
2023-11-02 REMS ORIG-1 0
2003-08-04 Review ORIG-1 0
1998-08-31 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "57"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074951", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "19"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "074951", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "074951", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "074951", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "074951", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 products INSERT {"ApplNo": "074951", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "074951"}