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

021842

NDA TAKEDA PHARMS USA
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 ACTOPLUS MET METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
002 ACTOPLUS MET METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 850MG;EQ 15MG BASE Prescription AB ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 25 AP 2024-06-28 LABELING STANDARD
SUPPL 22 AP 2017-12-21 LABELING STANDARD
SUPPL 20 AP 2016-12-12 EFFICACY STANDARD
SUPPL 21 AP 2016-12-12 LABELING 901 REQUIRED
SUPPL 19 AP 2014-08-16 LABELING STANDARD
SUPPL 18 AP 2013-08-15 MANUF (CMC) STANDARD
SUPPL 8 AP 2012-05-17 LABELING STANDARD
SUPPL 10 AP 2012-05-17 EFFICACY STANDARD
SUPPL 16 AP 2012-05-17 REMS N/A
SUPPL 14 AP 2011-08-04 REMS N/A
SUPPL 15 AP 2011-08-04 LABELING 901 REQUIRED
SUPPL 12 AP 2010-08-06 LABELING STANDARD
SUPPL 11 AP 2009-10-21 REMS UNKNOWN
SUPPL 9 AP 2009-09-14 LABELING STANDARD
SUPPL 7 AP 2009-01-04 LABELING STANDARD
SUPPL 5 AP 2007-09-26 LABELING STANDARD
SUPPL 2 AP 2006-11-04 LABELING STANDARD
SUPPL 3 AP 2006-09-28 LABELING STANDARD
SUPPL 1 AP 2006-08-30 LABELING STANDARD
ORIG 1 AP 2005-08-29 TYPE 4 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2024-07-01 Label SUPPL-25 0
2024-07-01 Medication Guide SUPPL-25 0
2017-12-27 Letter SUPPL-22 0
2017-12-26 Label SUPPL-22 0
2017-12-26 Medication Guide SUPPL-22 0
2017-01-09 Label SUPPL-21 0
2017-01-09 Label SUPPL-20 0
2016-12-14 Letter SUPPL-21 0
2016-12-13 Letter SUPPL-20 0
2014-08-20 Label SUPPL-19 0
2014-08-19 Letter SUPPL-19 0
2012-05-22 Label SUPPL-10 0
2012-05-22 Letter SUPPL-16 0
2012-05-22 Label SUPPL-8 0
2012-05-18 Letter SUPPL-10 0
2012-05-18 Letter SUPPL-8 0
2011-08-04 Letter SUPPL-14 0
2011-08-04 Label SUPPL-15 0
2011-08-04 Letter SUPPL-15 0
2011-08-04 Label SUPPL-14 0
2010-08-11 Letter SUPPL-12 0
2009-11-25 Letter SUPPL-11 0
2009-11-12 Other Important Information from FDA ORIG-1 0
2009-10-26 Letter SUPPL-9 0
2009-10-23 Label SUPPL-11 0
2009-01-06 Label SUPPL-7 0
2009-01-06 Letter SUPPL-7 0
2007-10-04 Letter SUPPL-5 0
2007-09-26 Label SUPPL-5 0
2007-01-22 Review ORIG-1 0
2006-11-07 Letter SUPPL-2 0
2006-11-06 Label SUPPL-2 0
2006-10-02 Letter SUPPL-3 0
2006-09-18 Letter SUPPL-1 0
2006-09-01 Label SUPPL-1 0
2005-08-31 Letter ORIG-1 0
2005-08-30 Patient Package Insert ORIG-1 0
2005-08-30 Label ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "50"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "50"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "5"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "51"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "25", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "21", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "20", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "15", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021842", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "021842", "ProductNo": "002", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "021842", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "021842", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "021842", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "021842", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "021842", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "021842"}