| NDC Code | 66215-101-06 |
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| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (66215-101-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
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| Product NDC | 66215-101 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Tracleer |
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| Non-Proprietary Name | Bosentan |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20011120 |
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| Marketing Category Name | NDA |
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| Application Number | NDA021290 |
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| Manufacturer | Actelion Pharmaceuticals US, Inc. |
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| Substance Name | BOSENTAN |
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| Strength | 62.5 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA] |
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