| NDC Code | 65862-631-99 |
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| Package Description | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-631-99) |
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| Product NDC | 65862-631 |
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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 | 20160331 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA203630 |
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| Manufacturer | Aurobindo Pharma Limited |
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| Substance Name | HYDROCHLOROTHIAZIDE; IRBESARTAN |
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| Strength | 25; 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 [CS] |
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