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

040260

ANDA SUN PHARM INDUSTRIES
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 23 AP 2026-06-18 REMS
SUPPL 22 AP 2025-03-14 LABELING STANDARD
SUPPL 21 AP 2024-11-21 LABELING STANDARD
SUPPL 20 AP 2024-10-31 REMS
SUPPL 19 AP 2021-05-04 LABELING STANDARD
SUPPL 18 AP 2021-03-04 LABELING STANDARD
SUPPL 17 AP 2019-10-09 LABELING STANDARD
SUPPL 16 AP 2018-09-20 LABELING STANDARD
SUPPL 15 AP 2018-09-18 REMS
SUPPL 14 AP 2017-03-07 LABELING STANDARD
SUPPL 12 AP 2016-12-16 LABELING STANDARD
SUPPL 13 AP 2016-12-16 LABELING STANDARD
SUPPL 9 AP 2002-07-24 MANUF (CMC)
SUPPL 8 AP 2002-02-08 MANUF (CMC)
SUPPL 6 AP 2001-11-02 MANUF (CMC)
SUPPL 7 AP 2001-09-24 MANUF (CMC)
SUPPL 2 AP 2000-12-18 MANUF (CMC)
SUPPL 3 AP 2000-12-18 MANUF (CMC)
SUPPL 4 AP 2000-12-18 MANUF (CMC)
SUPPL 5 AP 2000-12-18 MANUF (CMC)
ORIG 1 AP 1998-07-17
Documents (latest 100)
DateTypeSubmissionTitle / Link
2023-11-02 REMS ORIG-1 0
1998-07-17 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "57"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "36"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "36"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "35"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "36"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "36"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "36"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "36"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "23", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "21", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "20", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "15", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "040260", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "040260", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "040260", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "040260"}