APPLICATION
ANDA208811
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-23
LATEST ACTION
2024-12-04
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
FULVESTRANTDiscontinued
FULVESTRANT 250MG/5ML (50MG/ML) · SOLUTION · INTRAMUSCULAR
Approval history
2024-12-04Labeling · Supplement 2 · standardAP
2024-12-04Labeling · Supplement 3 · standardAP
2024-12-04Labeling · Supplement 8 · standardAP
2024-12-04Labeling · Supplement 4 · standardAP
2019-07-23UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.