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

021410

NDA SB PHARMCO
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 AVANDAMET METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE TABLET;ORAL 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
002 AVANDAMET METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE TABLET;ORAL 500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
003 AVANDAMET METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE TABLET;ORAL 500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
004 AVANDAMET METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE TABLET;ORAL 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
005 AVANDAMET METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE TABLET;ORAL 1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 40 AP 2017-04-05 LABELING 901 REQUIRED
SUPPL 39 AP 2015-12-16 REMS N/A
SUPPL 38 AP 2014-05-07 REMS N/A
SUPPL 37 AP 2014-05-07 LABELING 901 REQUIRED
SUPPL 36 AP 2014-05-07 REMS N/A
SUPPL 34 AP 2013-09-16 REMS N/A
SUPPL 33 AP 2013-06-11 MANUF (CMC) STANDARD
SUPPL 32 AP 2013-01-25 REMS N/A
SUPPL 30 AP 2012-05-30 REMS N/A
SUPPL 29 AP 2011-11-13 REMS N/A
SUPPL 27 AP 2011-05-18 REMS N/A
SUPPL 26 AP 2011-02-03 LABELING STANDARD
SUPPL 25 AP 2008-12-02 LABELING STANDARD
SUPPL 22 AP 2007-09-20 LABELING STANDARD
SUPPL 23 AP 2007-08-21 LABELING STANDARD
SUPPL 19 AP 2007-04-23 LABELING STANDARD
SUPPL 16 AP 2007-01-31 EFFICACY STANDARD
SUPPL 10 AP 2006-05-19 EFFICACY UNKNOWN
SUPPL 13 AP 2006-04-19 LABELING STANDARD
SUPPL 9 AP 2005-01-04 LABELING STANDARD
SUPPL 6 AP 2004-05-19 LABELING STANDARD
SUPPL 5 AP 2004-05-19 LABELING STANDARD
SUPPL 1 AP 2003-08-25 MANUF (CMC) STANDARD
ORIG 1 AP 2002-10-10 TYPE 4 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2017-04-12 Letter SUPPL-40 0
2017-04-11 Label SUPPL-40 0
2017-04-11 Medication Guide SUPPL-40 0
2015-12-17 Letter SUPPL-39 0
2014-05-12 Label SUPPL-36 0
2014-05-12 Label SUPPL-38 0
2014-05-12 Label SUPPL-37 0
2014-05-08 Letter SUPPL-36 0
2014-05-08 Letter SUPPL-37 0
2014-05-08 Letter SUPPL-38 0
2013-09-19 Letter SUPPL-34 0
2013-01-30 Letter SUPPL-32 0
2012-06-06 Label SUPPL-30 0
2012-06-04 Letter SUPPL-30 0
2011-11-21 Letter SUPPL-29 0
2011-11-16 Label SUPPL-29 0
2011-05-24 Letter SUPPL-27 0
2011-05-17 Label SUPPL-27 0
2011-02-04 Label SUPPL-26 0
2011-02-03 Letter SUPPL-26 0
2009-09-14 Review SUPPL-9 0
2008-12-04 Letter SUPPL-25 0
2008-12-04 Label SUPPL-25 0
2008-02-21 Other Important Information from FDA ORIG-1 0
2007-09-26 Label SUPPL-22 0
2007-09-25 Letter SUPPL-22 0
2007-08-22 Letter SUPPL-23 0
2007-08-22 Label SUPPL-23 0
2007-05-01 Letter SUPPL-19 0
2007-04-25 Label SUPPL-19 0
2007-02-12 Letter SUPPL-16 0
2007-02-02 Label SUPPL-16 0
2006-05-22 Letter SUPPL-10 0
2006-05-22 Label SUPPL-10 0
2006-04-21 Letter SUPPL-13 0
2006-04-20 Label SUPPL-13 0
2005-03-01 Letter SUPPL-9 0
2005-01-11 Label SUPPL-9 0
2004-05-27 Label SUPPL-5 0
2004-05-27 Label SUPPL-6 0
2004-05-26 Letter SUPPL-6 0
2004-05-26 Letter SUPPL-5 0
2003-08-28 Letter SUPPL-1 0
2003-08-28 Label SUPPL-1 0
2003-04-30 Review ORIG-1 0
2002-10-10 Label ORIG-1 0
2000-05-09 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "34", "ActionTypes_LookupID": "51"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "51"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "50"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "51"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "8"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "51"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "53"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "39", "ActionTypes_LookupID": "51"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "51"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "51"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "34", "ActionTypes_LookupID": "50"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "29", "ActionTypes_LookupID": "51"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "8"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "37"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "40", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "39", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "38", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "37", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "36", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "34", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "32", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "29", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "26", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "25", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
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2026-07-12 marketing_status INSERT {"ApplNo": "021410", "ProductNo": "005"}
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2026-07-12 marketing_status INSERT {"ApplNo": "021410", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "021410", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
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2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "26"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "29"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "32"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "34"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "36"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "39"}
2026-07-12 submissions INSERT {"ApplNo": "021410", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 products INSERT {"ApplNo": "021410", "ProductNo": "005"}
2026-07-12 products INSERT {"ApplNo": "021410", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "021410", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "021410", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "021410", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "021410"}