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

021574

NDA ANDRX LABS LLC
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 FORTAMET METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
002 FORTAMET METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Discontinued AB2 ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 17 AP 2018-11-08 LABELING STANDARD
SUPPL 20 AP 2017-04-05 LABELING 901 REQUIRED
SUPPL 18 AP 2015-05-18 MANUF (CMC) STANDARD
SUPPL 10 AP 2008-07-29 LABELING STANDARD
SUPPL 6 AP 2007-04-19 LABELING STANDARD
SUPPL 5 AP 2006-02-08 LABELING STANDARD
ORIG 1 AP 2004-04-27 TYPE 5 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2018-11-15 Letter SUPPL-17 0
2018-11-12 Label SUPPL-17 0
2017-04-12 Letter SUPPL-20 0
2017-04-11 Label SUPPL-20 0
2008-08-13 Label SUPPL-10 0
2008-07-31 Letter SUPPL-10 0
2007-04-25 Letter SUPPL-6 0
2007-04-20 Label SUPPL-6 0
2006-02-22 Letter SUPPL-5 0
2006-02-08 Review ORIG-1 0
2004-05-04 Label ORIG-1 0
2004-04-29 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021574", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "48"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "20", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "021574", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "021574", "ProductNo": "002", "TECode": "AB2"}
2026-07-12 marketing_status INSERT {"ApplNo": "021574", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "021574", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "021574", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "021574", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "021574", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "021574", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "021574"}