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ELMIRON
ELMIRON - 50458-098-01 - (PENTOSAN POLYSULFATE SODIUM)
Drug Information of ELMIRON
| Product NDC: | 50458-098 |
| Proprietary Name: | ELMIRON |
| Non Proprietary Name: | PENTOSAN POLYSULFATE SODIUM |
| Active Ingredient(s): | 100 mg/1 & nbsp; PENTOSAN POLYSULFATE SODIUM |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, GELATIN COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of ELMIRON
| Product NDC: | 50458-098 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020193 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19960926 |
Package Information of ELMIRON
| Package NDC: | 50458-098-01 |
| Package Description: | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01) |
NDC Information of ELMIRON
| NDC Code | 50458-098-01 |
| Proprietary Name | ELMIRON |
| Package Description | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01) |
| Product NDC | 50458-098 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | PENTOSAN POLYSULFATE SODIUM |
| Dosage Form Name | CAPSULE, GELATIN COATED |
| Route Name | ORAL |
| Start Marketing Date | 19960926 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | PENTOSAN POLYSULFATE SODIUM |
| Strength Number | 100 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Glycosaminoglycan [EPC],Glycosaminoglycans [Chemical/Ingredient] |
