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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) 050813 | 001 | MOXATAGP | AMOXICILLIN | 阿莫西林 | TABLET, EXTENDED RELEASE;ORAL | 775MG | PRAGMA | 2008-01-23 | Yes | No | DISCN | |
(NDA) 050760 | 001 | AMOXIL | AMOXICILLIN | 阿莫西林 | FOR SUSPENSION;ORAL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | US ANTIBIOTICS | 1999-04-15 | Yes | No | DISCN | |
(NDA) 050760 | 002 | AMOXIL | AMOXICILLIN | 阿莫西林 | FOR SUSPENSION;ORAL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | US ANTIBIOTICS | 1999-04-15 | Yes | No | RX | AB |
(NDA) 050754 | 001 | AMOXIL | AMOXICILLIN | 阿莫西林 | TABLET;ORAL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | US ANTIBIOTICS | 1998-07-10 | Yes | No | DISCN | |
(NDA) 050754 | 002 | AMOXIL | AMOXICILLIN | 阿莫西林 | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | US ANTIBIOTICS | 1998-07-10 | Yes | No | DISCN | |
(NDA) 050542 | 001 | AMOXIL | AMOXICILLIN | 阿莫西林 | TABLET, CHEWABLE;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | US ANTIBIOTICS | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050542 | 002 | AMOXIL | AMOXICILLIN | 阿莫西林 | TABLET, CHEWABLE;ORAL | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | US ANTIBIOTICS | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050460 | 001 | AMOXIL | AMOXICILLIN | 阿莫西林 | FOR SUSPENSION;ORAL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXOSMITHKLINE | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050460 | 002 | AMOXIL | AMOXICILLIN | 阿莫西林 | FOR SUSPENSION;ORAL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXOSMITHKLINE | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050460 | 005 | AMOXIL | AMOXICILLIN | 阿莫西林 | FOR SUSPENSION;ORAL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXOSMITHKLINE | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050460 | 006 | LAROTID | AMOXICILLIN | 阿莫西林 | FOR SUSPENSION;ORAL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXOSMITHKLINE | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050459 | 001 | AMOXIL | AMOXICILLIN | 阿莫西林 | CAPSULE;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXOSMITHKLINE | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050459 | 002 | AMOXIL | AMOXICILLIN | 阿莫西林 | CAPSULE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GLAXOSMITHKLINE | 1982-01-01 | Yes | No | DISCN |