NDC Code | 85043-316-70 |
Package Description | 1 SYRINGE in 1 CARTON (85043-316-70) / .5 mL in 1 SYRINGE |
Product NDC | 85043-316 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Leuprolide Acetate For Injectable Suspension |
Non-Proprietary Name | Leuprolide Acetate |
Dosage Form | INJECTION, SUSPENSION, EXTENDED RELEASE |
Usage | SUBCUTANEOUS |
Start Marketing Date | 20250601 |
Marketing Category Name | NDA AUTHORIZED GENERIC |
Application Number | NDA021488 |
Manufacturer | URONOVA PHARMACEUTICALS, INC. |
Substance Name | LEUPROLIDE ACETATE |
Strength | 30 |
Strength Unit | mg/.5mL |
Pharmacy Classes | Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA] |