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

040910

ANDA EPIC PHARMA LLC
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;4.8355MG Discontinued AA
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 6 AP 2026-06-18 REMS
SUPPL 5 AP 2025-03-07 LABELING STANDARD
SUPPL 4 AP 2024-11-21 LABELING STANDARD
SUPPL 3 AP 2024-10-31 REMS
ORIG 1 AP 2020-07-16
Documents (latest 100)
DateTypeSubmissionTitle / Link
2023-11-07 REMS ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040910", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "51"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "51"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "18"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "040910", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "040910", "ProductNo": "001", "TECode": "AA"}
2026-07-12 marketing_status INSERT {"ApplNo": "040910", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "040910", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "040910", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "040910", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "040910"}