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

211563

ANDA ALKEM LABS LTD
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG Prescription AB
002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;1GM Prescription AB
003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;500MG Prescription AB
004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM Prescription AB
Submissions
Type#StatusDate ClassReview PriorityNotes
ORIG 1 AP 2026-04-06 UNKNOWN STANDARD
ORIG 2 TA 2026-04-06 UNKNOWN STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2026-06-09 Letter ORIG-1 0
2026-06-09 Letter ORIG-2 0
2026-05-26 Label ORIG-2 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "211563", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "211563", "SubmissionType": "ORIG", "SubmissionNo": "2", "ActionTypes_LookupID": "46"}
2026-07-12 submission_property_type INSERT {"ApplNo": "211563", "SubmissionType": "ORIG", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "211563", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "211563", "ProductNo": "004", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "211563", "ProductNo": "003", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "211563", "ProductNo": "002", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "211563", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "211563", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "211563", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "211563", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "211563", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "211563", "SubmissionType": "ORIG", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "211563", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "211563", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "211563", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "211563", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "211563", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "211563"}