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

205479

ANDA LGM PHARMA
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 HYDROCODONE BITARTRATE AND ASPIRIN ASPIRIN; HYDROCODONE BITARTRATE TABLET;ORAL 500MG;5MG Prescription ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 8 AP 2026-06-18 REMS
SUPPL 6 AP 2026-01-02 LABELING STANDARD
SUPPL 5 AP 2024-11-22 LABELING STANDARD
SUPPL 4 AP 2024-10-31 REMS
SUPPL 3 AP 2024-10-03 LABELING STANDARD
SUPPL 1 AP 2024-01-03 LABELING STANDARD
SUPPL 2 AP 2024-01-03 LABELING STANDARD
ORIG 1 AP 2021-05-28 UNKNOWN STANDARD
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": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "205479", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "27"}
2026-07-12 submission_property_type INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "205479", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "205479", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "205479", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "205479", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "205479", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "205479"}