APPLICATION
ANDA075471
TYPE
ANDA
ORIGINAL APPROVAL
2000-10-25
LATEST ACTION
2026-05-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEUPROLIDE ACETATEPrescription
LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) · SOLUTION · SUBCUTANEOUS
Approval history
2026-05-06Labeling · Supplement 48 · standardAP
2025-09-23Labeling · Supplement 45 · standardAP
2025-09-19Labeling · Supplement 37 · standardAP
2025-09-19Labeling · Supplement 38 · standardAP
2017-05-19Labeling · Supplement 35 · standardAP
2017-05-19Labeling · Supplement 33 · standardAP
2017-05-19Labeling · Supplement 36 · standardAP
2013-01-31Labeling · Supplement 26 · standardAP
2012-08-09Labeling · Supplement 24AP
2011-03-28Labeling · Supplement 16AP
2009-05-27Labeling · Supplement 7AP
2001-09-20Manufacturing (CMC) · Supplement 1AP
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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