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

085470

ANDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 DEPO-ESTRADIOL ESTRADIOL CYPIONATE INJECTABLE;INJECTION 1MG/ML Discontinued
002 DEPO-ESTRADIOL ESTRADIOL CYPIONATE INJECTABLE;INJECTION 3MG/ML Discontinued
003 DEPO-ESTRADIOL ESTRADIOL CYPIONATE INJECTABLE;INJECTION 5MG/ML Prescription ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 27 AP 2024-02-21 LABELING STANDARD
SUPPL 23 AP 2019-05-03 LABELING STANDARD
SUPPL 15 AP 2005-06-15 LABELING
SUPPL 13 AP 2002-05-28 MANUF (CMC)
SUPPL 12 AP 2000-04-05 MANUF (CMC)
SUPPL 10 AP 1998-06-01 LABELING
SUPPL 3 AP 1982-07-01 MANUF (CMC)
SUPPL 4 AP 1982-07-01 MANUF (CMC)
ORIG 1 AP 1979-08-15
Documents (latest 100)
DateTypeSubmissionTitle / Link
2009-09-30 Label SUPPL-15 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "085470", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "39"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "36"}
2026-07-12 submission_property_type INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "23", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "085470", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "085470", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "085470", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "085470", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "085470", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "085470", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "085470", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "085470", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "085470"}