Data as of 2026-09-09 — 792,868 rows loaded

013416

NDA BAUSCH
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
003 NORGESIC ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET;ORAL 385MG;30MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
004 NORGESIC FORTE ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET;ORAL 770MG;60MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 30 AP 2021-04-28 LABELING STANDARD
SUPPL 21 AP 2002-11-25 LABELING
SUPPL 29 AP 1999-03-26 MANUF (CMC) STANDARD
SUPPL 28 AP 1997-09-12 MANUF (CMC) STANDARD
SUPPL 27 AP 1995-06-13 MANUF (CMC) STANDARD
SUPPL 26 AP 1993-12-16 MANUF (CMC) STANDARD
SUPPL 23 AP 1993-11-05 MANUF (CMC) STANDARD
SUPPL 24 AP 1988-03-30 MANUF (CMC) STANDARD
SUPPL 22 AP 1987-04-28 MANUF (CMC) STANDARD
SUPPL 20 AP 1986-01-31 LABELING
SUPPL 11 AP 1977-07-27 MANUF (CMC) STANDARD
SUPPL 12 AP 1977-07-27 MANUF (CMC) STANDARD
ORIG 1 AP 1964-03-04 TYPE 4 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2021-04-29 Letter SUPPL-30 0
2021-04-29 Label SUPPL-30 0
2002-11-25 Letter SUPPL-21 0
Change History (all loads)
DateTableChangeKey
2026-09-04 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-09-02 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-09-01 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-31 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-28 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-26 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-25 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-24 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-20 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-19 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-17 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-14 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-13 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-11 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-07 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-08-04 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-31 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-29 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-28 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-27 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-23 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-22 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-17 submission_property_type UPDATE {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "29", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "42"}
2026-07-12 submission_property_type INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "29", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "26", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "24", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "23", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "013416", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "013416", "ProductNo": "003"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "29"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "26"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "013416", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "013416", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "013416", "ProductNo": "003"}
2026-07-12 applications INSERT {"ApplNo": "013416"}