leuprolide acetate

FDA Drug Profile — Lupron Depot, leuprolide acetate, Lupron Depot-PED, Leuprolide Acetate, LUTRATE DEPOT

Drug Details

Generic Name
leuprolide acetate
Brand Names
Lupron Depot, leuprolide acetate, Lupron Depot-PED, Leuprolide Acetate, LUTRATE DEPOT, LEUPROLIDE ACETATE DEPOT
Application Number
NDA020708
Sponsor
Takeda Pharmaceutical Company Limited
NDC Codes
31
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.