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

078804

ANDA BARR
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 ASPIRIN AND DIPYRIDAMOLE ASPIRIN; DIPYRIDAMOLE CAPSULE, EXTENDED RELEASE;ORAL 25MG;200MG Prescription AB
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 10 AP 2022-08-05 LABELING STANDARD
SUPPL 6 AP 2020-02-27 LABELING STANDARD
SUPPL 7 AP 2020-02-27 LABELING STANDARD
SUPPL 2 AP 2018-05-02 MANUF (CMC) UNKNOWN
ORIG 1 AP 2009-08-14
Documents (latest 100)
DateTypeSubmissionTitle / Link
2009-08-21 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "28"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "28"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "28"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "078804", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 submission_property_type INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "078804", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "078804", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "078804", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "078804", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "078804", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "078804", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "078804"}