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

077507

ANDA EPIC PHARMA LLC
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;250MG Prescription AB
002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;500MG Prescription AB
003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE TABLET;ORAL 5MG;500MG Prescription AB
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 4 AP 2017-04-05 LABELING STANDARD
SUPPL 3 AP 2010-08-26 LABELING
SUPPL 2 AP 2009-10-26 LABELING
ORIG 1 AP 2005-10-27
Documents (latest 100)
DateTypeSubmissionTitle / Link
2005-11-01 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "077507", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "077507", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "077507", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "077507", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "27"}
2026-07-12 submission_property_type INSERT {"ApplNo": "077507", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "077507", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "077507", "ProductNo": "003", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "077507", "ProductNo": "002", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "077507", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "077507", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "077507", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "077507", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "077507", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "077507", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "077507", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "077507", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 products INSERT {"ApplNo": "077507", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "077507", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "077507", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "077507"}