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申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(NDA) 007638 | 001 | CHLOR-TRIMETON | CHLORPHENIRAMINE MALEATE | 马来酸氯苯那敏 | TABLET, EXTENDED RELEASE;ORAL | 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BAYER HEALTHCARE LLC | 1982-01-01 | Yes | No | DISCN | |
(NDA) 007638 | 002 | CHLOR-TRIMETON | CHLORPHENIRAMINE MALEATE | 马来酸氯苯那敏 | TABLET, EXTENDED RELEASE;ORAL | 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BAYER HEALTHCARE LLC | 1982-01-01 | Yes | No | DISCN |