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

022024

NDA TAKEDA PHARMS USA
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 ACTOPLUS MET XR METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM;EQ 15MG BASE Discontinued ✓
002 ACTOPLUS MET XR METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM;EQ 30MG BASE Discontinued ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 14 AP 2017-12-21 LABELING STANDARD
SUPPL 13 AP 2016-12-12 LABELING 901 REQUIRED
SUPPL 12 AP 2016-12-12 EFFICACY STANDARD
SUPPL 11 AP 2015-03-16 MANUF (CMC) STANDARD
SUPPL 1 AP 2013-11-12 LABELING STANDARD
SUPPL 10 AP 2013-09-27 MANUF (CMC) STANDARD
SUPPL 9 AP 2012-05-17 REMS N/A
SUPPL 8 AP 2011-08-04 REMS N/A
SUPPL 7 AP 2011-08-04 LABELING 901 REQUIRED
SUPPL 2 AP 2010-12-22 LABELING UNKNOWN
ORIG 1 AP 2009-05-12 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2017-12-27 Letter SUPPL-14 0
2017-12-26 Label SUPPL-14 0
2017-12-26 Medication Guide SUPPL-14 0
2016-12-15 Label SUPPL-13 0
2016-12-14 Letter SUPPL-13 0
2016-12-13 Letter SUPPL-12 0
2013-11-14 Letter SUPPL-1 0
2013-11-14 Label SUPPL-1 0
2012-05-22 Letter SUPPL-9 0
2011-08-04 Letter SUPPL-8 0
2011-08-04 Label SUPPL-8 0
2011-08-04 Letter SUPPL-7 0
2011-08-04 Label SUPPL-7 0
2010-12-28 Letter SUPPL-2 0
2010-12-26 Label SUPPL-2 0
2010-03-25 Review ORIG-1 0
2009-11-12 Other Important Information from FDA ORIG-1 0
2009-07-08 Label ORIG-1 0
2009-05-14 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "48"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "50"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "53"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "51"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022024", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "022024", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "022024", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "022024", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "022024", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 products INSERT {"ApplNo": "022024", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "022024", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "022024"}