商品名 | Zenpep |
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申请号 | 022210 |
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产品号 | 8 |
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BLA类型 | 351(a) |
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非专利名称 | pancrelipase |
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剂型 | Capsule, Delayed Release |
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给药途径 | Oral |
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规格/剂量 | 60,000USP UNITS; 189,600USP UNITS; 252,600USP UNITS |
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产品形式 | |
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批准日期 | 2023/10/27 |
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申请人 | Zenpep, LLC |
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市场状态 | Rx |
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许可证号 | 2198 |
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许可证状态 | Licensed |
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参考产品非专利名称 | |
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参考产品专利名称 | |
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申请类型 | Supplement |
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申请提交号 | 27 |
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数据来源 | CDER |
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首次许可日期 | |
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罕用药专营权到期日 | |
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同申请号产品 | - Zenpep, Capsule, Delayed Release, 5,000USP UNITS; 17,000USP UNITS; 24,000USP UNITS
- Zenpep, Capsule, Delayed Release, 10,000USP UNITS; 32,000USP UNITS; 42,000USP UNITS
- Zenpep, Capsule, Delayed Release, 15,000USP UNITS; 47,000USP UNITS; 63,000USP UNITS
- Zenpep, Capsule, Delayed Release, 20,000USP UNITS; 63,000USP UNITS; 84,000USP UNITS
- Zenpep, Capsule, Delayed Release, 3,000USP UNITS; 10,000USP UNITS; 14,000USP UNITS
- Zenpep, Capsule, Delayed Release, 25,000USP UNITS; 79,000USP UNITS; 105,000USP UNITS
- Zenpep, Capsule, Delayed Release, 40,000USP UNITS; 126,000USP UNITS; 168,000USP UNITS
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相关数据 | |
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