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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) 215153 | 001 | VOQUEZNA DUAL PAKP | AMOXICILLIN; VONOPRAZAN FUMARATE | 阿莫西林;富马酸伏诺拉生 | CAPSULE, TABLET;ORAL | 500MG;EQ 20MG BASE | PHATHOM | 2022-05-03 | Yes | Yes | RX | |
| (NDA) 215152 | 001 | VOQUEZNA TRIPLE PAKP | AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE | 阿莫西林;克拉霉素;富马酸伏诺拉生 | CAPSULE, TABLET, TABLET;ORAL | 500MG;500MG;EQ 20MG BASE | PHATHOM | 2022-05-03 | Yes | Yes | RX | |
| (NDA) 213004 | 001 | TALICIAP | AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN | 阿莫西林;奥美拉唑镁;利福布汀 | CAPSULE, DELAYED RELEASE;ORAL | 250MG;EQ 10MG BASE;12.5MG | REDHILL | 2019-11-01 | Yes | Yes | RX | |
| (NDA) 050824 | 001 | OMECLAMOX-PAK | AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE | 阿莫西林;克拉霉素;奥美拉唑 | CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CUMBERLAND | 2011-02-08 | Yes | No | DISCN | |
| (NDA) 050813 | 001 | MOXATAGP | AMOXICILLIN | 阿莫西林 | TABLET, EXTENDED RELEASE;ORAL | 775MG | PRAGMA | 2008-01-23 | Yes | No | DISCN | |
| (NDA) 050785 | 001 | AUGMENTIN XR | AMOXICILLIN; CLAVULANATE POTASSIUM | 阿莫西林;克拉维酸钾 | TABLET, EXTENDED RELEASE;ORAL | 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | US ANTIBIOTICS | 2002-09-25 | Yes | No | DISCN | |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| 阿莫西林 | FOR SUSPENSION;ORAL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | US ANTIBIOTICS | 1999-04-15 | Yes | No | DISCN | |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| 阿莫西林 | FOR SUSPENSION;ORAL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | US ANTIBIOTICS | 1999-04-15 | Yes | No | RX | AB |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) 050757 | 001 | PREVPAC (COPACKAGED) | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 阿莫西林;克拉霉素;兰索拉唑 | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TAKEDA PHARMS USA | 1997-12-02 | Yes | No | DISCN | |
| (NDA) 050755 | 001 | AUGMENTIN ES-600 | AMOXICILLIN; CLAVULANATE POTASSIUM | 阿莫西林;克拉维酸钾 | FOR SUSPENSION;ORAL | 600MG/5ML;EQ 42.9MG BASE/5ML | US ANTIBIOTICS | 2001-06-22 | 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) 050726 | 001 | AUGMENTIN '200' | AMOXICILLIN; CLAVULANATE POTASSIUM | 阿莫西林;克拉维酸钾 | TABLET, CHEWABLE;ORAL | 200MG;EQ 28.5MG BASE | US ANTIBIOTICS | 1996-05-31 | Yes | No | DISCN | |
| (NDA) 050726 | 002 | AUGMENTIN '400' | AMOXICILLIN; CLAVULANATE POTASSIUM | 阿莫西林;克拉维酸钾 | TABLET, CHEWABLE;ORAL | 400MG;EQ 57MG BASE | US ANTIBIOTICS | 1996-05-31 | Yes | No | DISCN | |
| (NDA) 050725 | 001 | AUGMENTIN '200' | AMOXICILLIN; CLAVULANATE POTASSIUM | 阿莫西林;克拉维酸钾 | FOR SUSPENSION;ORAL | 200MG/5ML;EQ 28.5MG BASE/5ML | US ANTIBIOTICS | 1996-05-31 | Yes | No | DISCN | |
| (NDA) 050725 | 002 | AUGMENTIN '400' | AMOXICILLIN; CLAVULANATE POTASSIUM | 阿莫西林;克拉维酸钾 | FOR SUSPENSION;ORAL | 400MG/5ML;EQ 57MG BASE/5ML | US ANTIBIOTICS | 1996-05-31 | Yes | No | DISCN | |
| (NDA) 050720 | 001 | AUGMENTIN '875' | AMOXICILLIN; CLAVULANATE POTASSIUM | 阿莫西林;克拉维酸钾 | TABLET;ORAL | 875MG;EQ 125MG BASE | US ANTIBIOTICS | 1996-02-13 | Yes | No | RX | AB |
| (NDA) 050597 | 001 | AUGMENTIN '125' | AMOXICILLIN; CLAVULANATE POTASSIUM | 阿莫西林;克拉维酸钾 | TABLET, CHEWABLE;ORAL | 125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | US ANTIBIOTICS | 1985-07-22 | Yes | No | DISCN | |
| (NDA) 050597 | 002 | AUGMENTIN '250' | AMOXICILLIN; CLAVULANATE POTASSIUM | 阿莫西林;克拉维酸钾 | TABLET, CHEWABLE;ORAL | 250MG;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | US ANTIBIOTICS | 1985-07-22 | Yes | No | DISCN | |
| (NDA) 050575 | 001 | AUGMENTIN '125' | AMOXICILLIN; CLAVULANATE POTASSIUM | 阿莫西林;克拉维酸钾 | FOR SUSPENSION;ORAL | 125MG/5ML;EQ 31.25MG BASE/5ML | US ANTIBIOTICS | 1984-08-06 | Yes | No | RX | AB |
