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

212198

ANDA ZYDUS PHARMS
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 5MG;500MG Discontinued AB
002 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 5MG;1GM Discontinued AB
003 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 12.5MG;500MG Discontinued AB
004 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 12.5MG;1GM Discontinued AB
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 4 AP 2024-08-13 LABELING STANDARD
ORIG 1 AP 2022-07-07 UNKNOWN STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2022-08-30 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "212198", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "212198", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "212198", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "18"}
2026-07-12 submission_property_type INSERT {"ApplNo": "212198", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "212198", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "212198", "ProductNo": "004", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "212198", "ProductNo": "003", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "212198", "ProductNo": "002", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "212198", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "212198", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "212198", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "212198", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "212198", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "212198", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "212198", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "212198", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "212198", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "212198", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "212198", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "212198"}