| NDC Code | 43598-749-04 |
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| Package Description | 1 BOTTLE in 1 CARTON (43598-749-04) > 120 TABLET in 1 BOTTLE |
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| Product NDC | 43598-749 |
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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 | 20201001 |
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| Marketing Category Name | NDA |
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| Application Number | NDA022181 |
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| Manufacturer | Dr. Reddys Laboratories Inc. |
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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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