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

040118

ANDA SANDOZ
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE TABLET;ORAL 325MG;200MG;16MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 24 AP 2023-12-15 LABELING STANDARD
SUPPL 21 AP 2021-04-28 LABELING STANDARD
SUPPL 20 AP 2021-03-04 LABELING STANDARD
SUPPL 19 AP 2019-10-16 LABELING STANDARD
SUPPL 18 AP 2018-09-20 LABELING STANDARD
SUPPL 17 AP 2018-09-18 REMS
SUPPL 16 AP 2017-08-29 LABELING STANDARD
SUPPL 14 AP 2013-07-30 LABELING STANDARD
SUPPL 13 AP 2013-07-30 LABELING STANDARD
SUPPL 12 AP 2011-06-21 LABELING
SUPPL 11 AP 2008-08-13 LABELING
SUPPL 5 AP 2000-02-02 MANUF (CMC)
SUPPL 4 AP 1999-02-01 MANUF (CMC)
SUPPL 3 AP 1997-04-10 MANUF (CMC)
SUPPL 2 AP 1997-04-10 MANUF (CMC)
SUPPL 1 AP 1997-04-10 MANUF (CMC)
ORIG 1 AP 1996-04-16
Documents (latest 100)
DateTypeSubmissionTitle / Link
2023-11-03 REMS ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "57"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "24"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "24"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "24"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "36"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "24", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "21", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "20", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "040118", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "040118", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 products INSERT {"ApplNo": "040118", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "040118"}