leuprolide acetate

FDA Drug Profile — Lupron Depot, Lupron Depot-PED, LUTRATE DEPOT, leuprolide acetate, LEUPROLIDE ACETATE DEPOT

Drug Details

Generic Name
leuprolide acetate
Brand Names
Lupron Depot, Lupron Depot-PED, LUTRATE DEPOT, leuprolide acetate, LEUPROLIDE ACETATE DEPOT, Leuprolide Acetate
Application Number
NDA020708
Sponsor
Takeda Pharmaceutical Company Limited
NDC Codes
30
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, KIT
Routes
SUBCUTANEOUS
Active Ingredients
LEUPROLIDE ACETATE

Indications and Usage

1 INDICATIONS AND USAGE FENSOLVI is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). FENSOLVI is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.