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

074654

ANDA SANDOZ
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET;ORAL 385MG;30MG;25MG Discontinued
002 ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET;ORAL 770MG;60MG;50MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 21 AP 2024-11-21 LABELING STANDARD
SUPPL 20 AP 2024-09-30 LABELING STANDARD
SUPPL 19 AP 2021-04-28 LABELING STANDARD
SUPPL 4 AP 2000-09-13 MANUF (CMC)
SUPPL 3 AP 2000-02-02 MANUF (CMC)
SUPPL 2 AP 1999-09-14 MANUF (CMC)
SUPPL 1 AP 1999-01-08 MANUF (CMC)
ORIG 1 AP 1996-12-31
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074654", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "36"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "21", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "20", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "074654", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "074654", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "074654", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "074654", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "074654", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "074654", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "074654"}