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

040255

ANDA ANI PHARMS
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE TABLET;ORAL 325MG;4.5MG;0.38MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 35 AP 2026-06-18 REMS
SUPPL 34 AP 2025-03-14 LABELING STANDARD
SUPPL 33 AP 2024-11-21 LABELING STANDARD
SUPPL 32 AP 2024-10-31 REMS
SUPPL 31 AP 2021-04-28 LABELING STANDARD
SUPPL 30 AP 2021-03-04 LABELING STANDARD
SUPPL 29 AP 2019-10-08 LABELING STANDARD
SUPPL 28 AP 2018-09-21 LABELING STANDARD
SUPPL 27 AP 2018-09-18 REMS
SUPPL 26 AP 2017-06-29 LABELING STANDARD
SUPPL 24 AP 2016-12-16 LABELING STANDARD
SUPPL 25 AP 2016-12-16 LABELING STANDARD
SUPPL 6 AP 2004-12-13 LABELING
SUPPL 2 AP 2000-03-21 MANUF (CMC)
SUPPL 1 AP 1998-08-21 MANUF (CMC)
ORIG 1 AP 1998-02-27
Documents (latest 100)
DateTypeSubmissionTitle / Link
2023-11-03 REMS ORIG-1 0
1998-02-27 Review ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "29", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "34", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "57"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "36"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "35", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "34", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "32", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "31", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "29", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "26", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "25", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "24", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "040255", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "34"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "32"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "29"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "26"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "040255", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "040255", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "040255"}