APPLICATION
ANDA204246
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-30
LATEST ACTION
2026-06-16
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FYREMADELPrescription
GANIRELIX ACETATE 250MCG/0.5ML · INJECTABLE · INJECTION
Approval history
2026-06-16Labeling · Supplement 12 · standardAP
2024-07-26Labeling · Supplement 10 · standardAP
2021-03-16Manufacturing (CMC) · Supplement 6 · unknownAP
2019-05-03Labeling · Supplement 1 · standardAP
2018-11-30UNKNOWN · OriginalAP
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.