| NDC Code | 64380-198-03 |
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| Package Description | 500 TABLET, FILM COATED in 1 BOTTLE (64380-198-03) |
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| Product NDC | 64380-198 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Amlodipine, Valsartan, Hydrochlorothiazide |
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| Non-Proprietary Name | Amlodipine Besylate Valsartan Hydrochlorothiazide |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20220627 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA201087 |
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| Manufacturer | Strides Pharma Science Limited |
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| Substance Name | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
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| Strength | 5; 25; 160 |
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| Strength Unit | mg/1; mg/1; mg/1 |
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| Pharmacy Classes | Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS] |
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