APPLICATION
ANDA217437
TYPE
ANDA
ORIGINAL APPROVAL
2025-06-09
LATEST ACTION
2026-05-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LEUPROLIDE ACETATEDiscontinued
LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) · SOLUTION · SUBCUTANEOUS
Approval history
2026-05-06Labeling · Supplement 2 · standardAP
2025-06-09UNKNOWN · 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.
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