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

090084

ANDA ACTAVIS LABS FL INC
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;4.8355MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 15 AP 2026-06-18 REMS
SUPPL 14 AP 2025-02-28 LABELING STANDARD
SUPPL 13 AP 2024-11-21 LABELING STANDARD
SUPPL 12 AP 2024-10-31 REMS
SUPPL 11 AP 2021-05-03 LABELING STANDARD
SUPPL 10 AP 2021-03-04 LABELING STANDARD
SUPPL 8 AP 2019-10-08 LABELING STANDARD
SUPPL 7 AP 2018-09-21 LABELING STANDARD
SUPPL 5 AP 2018-09-18 REMS
SUPPL 6 AP 2018-09-11 LABELING STANDARD
ORIG 1 AP 2011-03-22
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": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "57"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "55"}
2026-07-12 submission_property_type INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "15", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "090084", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "090084", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "090084", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "090084", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "090084", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "090084"}