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

217049

ANDA ZYDUS PHARMS USA INC
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;2.5MG;1000MG None (Tentative Approval)
002 EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;5MG;1000MG None (Tentative Approval)
003 EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 12.5MG;2.5MG;1000MG None (Tentative Approval)
004 EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 25MG;5MG;1000MG None (Tentative Approval)
Submissions
Type#StatusDate ClassReview PriorityNotes
ORIG 1 TA 2025-11-25 UNKNOWN STANDARD
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "217049", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 submission_property_type INSERT {"ApplNo": "217049", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "217049", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "217049", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "217049", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "217049", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "217049", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "217049", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "217049", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "217049", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "217049", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "217049"}