APPLICATION
ANDA074728
TYPE
ANDA
ORIGINAL APPROVAL
1998-08-04
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 37 · standardAP
2026-04-30Labeling · Supplement 36 · standardAP
2025-09-23Labeling · Supplement 34 · standardAP
2021-02-01Labeling · Supplement 22 · standardAP
2021-02-01Labeling · Supplement 20 · standardAP
2017-05-19Labeling · Supplement 17 · standardAP
2017-05-19Labeling · Supplement 18 · standardAP
2015-11-17Labeling · Supplement 14 · standardAP
2011-03-28Labeling · Supplement 10AP
2008-07-06Labeling · Supplement 7AP
2006-09-13Labeling · Supplement 6AP
2001-04-03Manufacturing (CMC) · Supplement 2AP
1998-11-18Labeling · 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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