| NDC Code | 85043-465-60 |
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| Package Description | 1 SYRINGE in 1 CARTON (85043-465-60) / .375 mL in 1 SYRINGE |
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| Product NDC | 85043-465 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Leuprolide Acetate For Injectable Suspension |
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| Non-Proprietary Name | Leuprolide Acetate |
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| Dosage Form | INJECTION, SUSPENSION, EXTENDED RELEASE |
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| Usage | SUBCUTANEOUS |
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| Start Marketing Date | 20250901 |
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| Marketing Category Name | NDA AUTHORIZED GENERIC |
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| Application Number | NDA021731 |
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| Manufacturer | URONOVA PHARMACEUTICALS, INC. |
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| Substance Name | LEUPROLIDE ACETATE |
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| Strength | 45 |
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| Strength Unit | mg/.375mL |
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| Pharmacy Classes | Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA] |
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