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

210542

ANDA ZYDUS PHARMS USA INC
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET;ORAL 50MG;500MG None (Tentative Approval)
002 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET;ORAL 50MG;1000MG None (Tentative Approval)
003 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET;ORAL 150MG;500MG None (Tentative Approval)
004 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET;ORAL 150MG;1000MG None (Tentative Approval)
Submissions
Type#StatusDate ClassReview PriorityNotes
ORIG 1 TA 2023-02-16 UNKNOWN STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2023-03-15 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "210542", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 submission_property_type INSERT {"ApplNo": "210542", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "210542", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "210542", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "210542", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "210542", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "210542", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "210542", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "210542", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "210542", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "210542", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "210542"}