| NDC Code | 0955-1046-30 |
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| Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (0955-1046-30) |
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| Product NDC | 0955-1046 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Irbesartan And Hydrochlorothiazide |
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| Non-Proprietary Name | Irbesartan And Hydrochlorothiazide |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20120301 |
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| End Marketing Date | 20150331 |
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| Marketing Category Name | NDA |
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| Application Number | NDA020758 |
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| Manufacturer | Winthrop U.S. |
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| Substance Name | HYDROCHLOROTHIAZIDE; IRBESARTAN |
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| Strength | 12.5; 300 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] |
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