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

020884

NDA BOEHRINGER INGELHEIM
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 AGGRENOX ASPIRIN; DIPYRIDAMOLE CAPSULE, EXTENDED RELEASE;ORAL 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued AB ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 40 AP 2021-05-13 LABELING STANDARD
SUPPL 39 AP 2019-12-11 LABELING STANDARD
SUPPL 37 AP 2018-11-09 LABELING STANDARD
SUPPL 35 AP 2015-11-09 LABELING STANDARD
SUPPL 33 AP 2014-05-30 MANUF (CMC) PRIORITY
SUPPL 32 AP 2013-05-29 MANUF (CMC) PRIORITY
SUPPL 30 AP 2012-09-07 LABELING UNKNOWN
SUPPL 18 AP 2009-10-01 EFFICACY STANDARD
SUPPL 12 AP 2007-03-26 EFFICACY STANDARD
SUPPL 14 AP 2006-11-28 LABELING STANDARD
SUPPL 7 AP 2004-01-28 LABELING STANDARD
SUPPL 6 AP 2002-06-20 MANUF (CMC) PRIORITY
SUPPL 5 AP 2002-02-08 MANUF (CMC) PRIORITY
SUPPL 4 AP 2001-09-21 MANUF (CMC) PRIORITY
SUPPL 1 AP 2001-08-10 LABELING STANDARD
SUPPL 3 AP 2001-04-23 MANUF (CMC) PRIORITY
SUPPL 2 AP 2000-10-17 MANUF (CMC) PRIORITY
ORIG 1 AP 1999-11-22 TYPE 4 PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2021-05-17 Label SUPPL-40 0
2021-05-17 Letter SUPPL-40 0
2020-01-10 Label SUPPL-39 0
2019-12-12 Letter SUPPL-39 0
2018-11-15 Letter SUPPL-37 0
2018-11-13 Label SUPPL-37 0
2015-11-13 Letter SUPPL-35 0
2015-11-12 Label SUPPL-35 0
2012-09-11 Letter SUPPL-30 0
2012-09-11 Label SUPPL-30 0
2009-10-14 Label SUPPL-18 0
2009-10-05 Letter SUPPL-18 0
2007-03-31 Letter SUPPL-12 0
2007-03-31 Label SUPPL-12 0
2006-12-04 Letter SUPPL-14 0
2006-12-04 Label SUPPL-14 0
2004-02-02 Letter SUPPL-7 0
2003-04-30 Letter ORIG-1 0
2003-04-30 Label ORIG-1 0
2003-04-30 Review ORIG-1 0
2003-04-24 Label SUPPL-1 0
2001-04-23 Letter SUPPL-3 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "39", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "40", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "39", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "37", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "35", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "32", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "020884", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "020884", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "32"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "39"}
2026-07-12 submissions INSERT {"ApplNo": "020884", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 products INSERT {"ApplNo": "020884", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020884"}