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

010996

NDA XANODYNE PHARM
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
005 DARVON W/ ASA ASPIRIN; PROPOXYPHENE HYDROCHLORIDE CAPSULE;ORAL 325MG;65MG Discontinued
006 DARVON COMPOUND ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE CAPSULE;ORAL 389MG;32.4MG;32MG Discontinued
007 DARVON COMPOUND-65 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE CAPSULE;ORAL 389MG;32.4MG;65MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 68 AP 2004-05-27 MANUF (CMC) PRIORITY
SUPPL 61 AP 2002-08-01 LABELING PRIORITY
SUPPL 65 AP 1999-02-24 MANUF (CMC) PRIORITY
SUPPL 64 AP 1998-10-05 MANUF (CMC) PRIORITY
SUPPL 63 AP 1998-08-10 MANUF (CMC) PRIORITY
SUPPL 62 AP 1998-04-06 MANUF (CMC) PRIORITY
SUPPL 58 AP 1994-09-02 LABELING PRIORITY
SUPPL 55 AP 1994-08-23 LABELING PRIORITY
SUPPL 60 AP 1992-09-15 MANUF (CMC) PRIORITY
SUPPL 57 AP 1992-09-15 MANUF (CMC) PRIORITY
SUPPL 48 AP 1987-04-16 MANUF (CMC) PRIORITY
SUPPL 47 AP 1986-12-16 MANUF (CMC) PRIORITY
SUPPL 41 AP 1986-09-02 MANUF (CMC) PRIORITY
SUPPL 42 AP 1986-07-16 LABELING PRIORITY
SUPPL 40 AP 1986-04-21 LABELING PRIORITY
SUPPL 37 AP 1986-04-21 LABELING PRIORITY
SUPPL 36 AP 1985-01-28 MANUF (CMC) PRIORITY
SUPPL 35 AP 1983-03-08 MANUF (CMC) PRIORITY
SUPPL 34 AP 1981-10-28 LABELING PRIORITY
SUPPL 33 AP 1981-10-28 LABELING PRIORITY
SUPPL 32 AP 1981-05-20 LABELING PRIORITY
SUPPL 31 AP 1980-04-16 LABELING PRIORITY
SUPPL 24 AP 1980-01-18 MANUF (CMC) PRIORITY
SUPPL 30 AP 1979-09-26 LABELING PRIORITY
SUPPL 29 AP 1979-07-17 LABELING PRIORITY
SUPPL 28 AP 1979-03-26 LABELING PRIORITY
SUPPL 27 AP 1978-10-13 MANUF (CMC) PRIORITY
SUPPL 26 AP 1978-05-26 MANUF (CMC) PRIORITY
SUPPL 23 AP 1977-05-03 MANUF (CMC) PRIORITY
SUPPL 22 AP 1977-05-03 MANUF (CMC) PRIORITY
SUPPL 20 AP 1976-07-23 LABELING PRIORITY
SUPPL 14 AP 1975-01-06 LABELING PRIORITY
ORIG 1 AP 1957-11-12 TYPE 4 PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2004-06-01 Letter SUPPL-68 0
2002-08-01 Letter SUPPL-61 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "64", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "60", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "55", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "48", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "34", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "58", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "42", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "34"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "47", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "62", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "57", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "29", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "65", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "63", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "61", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "68", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "13"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "68", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "65", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "64", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "63", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "62", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "61", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "60", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "58", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "57", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "55", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "48", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "47", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "42", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "41", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "40", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "37", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "36", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "35", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "34", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "32", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "31", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "29", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "26", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "24", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "23", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "20", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "010996", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "010996", "ProductNo": "007"}
2026-07-12 marketing_status INSERT {"ApplNo": "010996", "ProductNo": "006"}
2026-07-12 marketing_status INSERT {"ApplNo": "010996", "ProductNo": "005"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "26"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "29"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "32"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "34"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "36"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "42"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "47"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "48"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "55"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "57"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "58"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "60"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "61"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "62"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "63"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "64"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "65"}
2026-07-12 submissions INSERT {"ApplNo": "010996", "SubmissionType": "SUPPL", "SubmissionNo": "68"}
2026-07-12 products INSERT {"ApplNo": "010996", "ProductNo": "007"}
2026-07-12 products INSERT {"ApplNo": "010996", "ProductNo": "006"}
2026-07-12 products INSERT {"ApplNo": "010996", "ProductNo": "005"}
2026-07-12 applications INSERT {"ApplNo": "010996"}