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SPORANOX
SPORANOX - 50458-295-15 - (itraconazole)
Drug Information of SPORANOX
| Product NDC: | 50458-295 |
| Proprietary Name: | SPORANOX |
| Non Proprietary Name: | itraconazole |
| Active Ingredient(s): | 10 mg/mL & nbsp; itraconazole |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of SPORANOX
| Product NDC: | 50458-295 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020657 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19970221 |
Package Information of SPORANOX
| Package NDC: | 50458-295-15 |
| Package Description: | 150 mL in 1 BOTTLE (50458-295-15) |
NDC Information of SPORANOX
| NDC Code | 50458-295-15 |
| Proprietary Name | SPORANOX |
| Package Description | 150 mL in 1 BOTTLE (50458-295-15) |
| Product NDC | 50458-295 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | itraconazole |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 19970221 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | ITRACONAZOLE |
| Strength Number | 10 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Azole Antifungal [EPC],Azoles [Chemical/Ingredient] |
