APPLICATION
ANDA213829
TYPE
ANDA
ORIGINAL APPROVAL
2021-08-13
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 6 · standardAP
2026-04-30Labeling · Supplement 5 · standardAP
2025-09-23Labeling · Supplement 4 · standardAP
2021-08-13UNKNOWN · 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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