| 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 | 20250901 |
|---|
| 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] |
|---|