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

063165

ANDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 ADRIAMYCIN PFS DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 2MG/ML Discontinued
002 ADRIAMYCIN PFS DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 200MG/100ML Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 12 AP 2011-12-05 LABELING
SUPPL 11 AP 2011-01-05 LABELING
SUPPL 10 AP 2002-08-16 MANUF (CMC)
SUPPL 9 AP 1999-08-24 LABELING
SUPPL 1 AP 1995-06-02 LABELING
SUPPL 2 AP 1995-06-02 LABELING
SUPPL 8 AP 1993-10-12 MANUF (CMC)
SUPPL 3 AP 1993-07-09 MANUF (CMC)
SUPPL 5 AP 1993-07-09 MANUF (CMC)
SUPPL 6 AP 1993-07-09 LABELING
SUPPL 7 AP 1993-05-19 MANUF (CMC)
SUPPL 4 AP 1992-06-01 MANUF (CMC)
ORIG 1 AP 1991-01-30
Documents (latest 100)
DateTypeSubmissionTitle / Link
2003-07-31 Review SUPPL-6 0
2003-07-31 Review SUPPL-3 0
2003-07-31 Review SUPPL-5 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "28"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "063165", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "063165", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "063165", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "063165", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "063165", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "063165"}