| NDC Code | 50458-098-01 |
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| Package Description | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01) |
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| Product NDC | 50458-098 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Elmiron |
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| Non-Proprietary Name | Pentosan Polysulfate Sodium |
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| Dosage Form | CAPSULE, GELATIN COATED |
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| Usage | ORAL |
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| Start Marketing Date | 19960926 |
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| Marketing Category Name | NDA |
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| Application Number | NDA020193 |
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| Manufacturer | Janssen Pharmaceuticals, Inc. |
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| Substance Name | PENTOSAN POLYSULFATE SODIUM |
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| Strength | 100 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Glycosaminoglycan [EPC], Glycosaminoglycans [CS] |
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