| NDC Code | 59651-574-08 |
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| Package Description | 120 TABLET in 1 BOTTLE (59651-574-08) |
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| Product NDC | 59651-574 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Sapropterin Dihydrochloride |
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| Non-Proprietary Name | Sapropterin Dihydrochloride |
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| Dosage Form | TABLET |
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| Usage | ORAL |
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| Start Marketing Date | 20250609 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA216797 |
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| Manufacturer | Aurobindo Pharma Limited |
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| Substance Name | SAPROPTERIN DIHYDROCHLORIDE |
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| Strength | 100 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA] |
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