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

087048

ANDA PURACAP PHARM
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
002 BUTALBITAL, ASPIRIN AND CAFFEINE ASPIRIN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 17 AP 2024-11-21 LABELING STANDARD
SUPPL 14 AP 1988-05-24 MANUF (CMC)
SUPPL 13 AP 1988-05-24 MANUF (CMC)
SUPPL 9 AP 1988-05-18 MANUF (CMC)
SUPPL 8 AP 1984-03-13 MANUF (CMC)
SUPPL 7 AP 1984-03-13 MANUF (CMC)
SUPPL 3 AP 1983-12-09 MANUF (CMC)
SUPPL 6 AP 1983-12-09 MANUF (CMC)
SUPPL 4 AP 1983-12-09 MANUF (CMC)
ORIG 1 AP 1980-04-30
Change History (all loads)
DateTableChangeKey
2026-09-09 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-09-09 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-08 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-09-08 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-08 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-09-04 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-09-04 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-04 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-09-02 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-09-02 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-01 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-09-01 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-09-01 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-31 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-31 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-28 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-28 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-28 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-26 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-26 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-26 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-25 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-25 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-25 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-24 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-24 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-24 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-21 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-21 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-21 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-20 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-20 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-20 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-19 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-19 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-18 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-18 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-18 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-17 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-17 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-14 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-14 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-13 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-13 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-13 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-12 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-12 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-12 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-11 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-11 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-11 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-10 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-10 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-10 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-07 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-07 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-07 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-05 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-05 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-08-05 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-08-04 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-08-04 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-31 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-31 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-31 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-29 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-29 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-28 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-28 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-28 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-27 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-27 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-27 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-24 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-24 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-24 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-23 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-23 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-23 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-22 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-22 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-22 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-17 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-17 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-17 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-15 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-15 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-15 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-14 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-14 join_submission_action_types UPDATE {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-14 submission_property_type UPDATE {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "087048", "ProductNo": "002"}
2026-07-12 submissions INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "087048", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "087048", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "087048", "ProductNo": "002"}
2026-07-12 applications INSERT {"ApplNo": "087048"}