| NDC Code | 85043-228-20 |
|---|
| Package Description | 1 SYRINGE in 1 CARTON (85043-228-20) / .375 mL in 1 SYRINGE |
|---|
| Product NDC | 85043-228 |
|---|
| 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 | NDA021379 |
|---|
| Manufacturer | URONOVA PHARMACEUTICALS, INC. |
|---|
| Substance Name | LEUPROLIDE ACETATE |
|---|
| Strength | 22.5 |
|---|
| Strength Unit | mg/.375mL |
|---|
| Pharmacy Classes | Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA] |
|---|