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FDA NDA · NDA205054

LUTRATE DEPOT

leuprolide acetate

Sponsor: INVAGEN PHARMS

APPLICATION
NDA205054
TYPE
NDA
ORIGINAL APPROVAL
2018-08-28
LATEST ACTION
2024-11-14
ROUTE
INTRAMUSCULAR
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

LEUPROLIDE ACETATE FOR DEPOT SUSPENSION · ReferencePrescription
LEUPROLIDE ACETATE 22.5MG/VIAL · FOR SUSPENSION · INTRAMUSCULAR

Approval history

2024-11-14Labeling · Supplement 7 · standard — Label ↗AP
2024-08-08Labeling · Supplement 6 · standard — Letter ↗AP
2023-11-30Labeling · Supplement 5 · standard — Label ↗AP
2023-02-28Efficacy · Supplement 4 · standard — Letter ↗AP
2018-08-28Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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