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

075231

ANDA LGM PHARMA
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 16 AP 2026-06-18 REMS
SUPPL 14 AP 2025-12-22 LABELING STANDARD
SUPPL 13 AP 2025-05-09 LABELING STANDARD
SUPPL 12 AP 2024-10-31 REMS
SUPPL 11 AP 2024-02-12 LABELING STANDARD
SUPPL 10 AP 2024-02-12 LABELING STANDARD
SUPPL 9 AP 2024-02-12 LABELING STANDARD
SUPPL 7 AP 2024-02-12 LABELING STANDARD
SUPPL 8 AP 2018-09-18 REMS
SUPPL 6 AP 2015-11-20 LABELING STANDARD
SUPPL 2 AP 2002-12-17 LABELING
SUPPL 1 AP 2002-12-17 MANUF (CMC)
SUPPL 3 AP 2002-08-20 MANUF (CMC)
ORIG 1 AP 2001-11-30
Documents (latest 100)
DateTypeSubmissionTitle / Link
2023-11-03 REMS ORIG-1 0
2003-04-10 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "57"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "24"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "24"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "42"}
2026-07-12 submission_property_type INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "075231", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "075231", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "075231", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 products INSERT {"ApplNo": "075231", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "075231"}