| NDC Code | 72319-012-03 |
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| Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03) |
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| Product NDC | 72319-012 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Isosorbide Dinitrate And Hydralazine Hydrochloride |
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| Non-Proprietary Name | Isosorbide Dinitrate And Hydralazine Hydrochloride |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20240207 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA215988 |
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| Manufacturer | i3 Pharmaceuticals, LLC |
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| Substance Name | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE |
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| Strength | 37.5; 20 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE] |
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