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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) 021131 | 003 | ZYVOX | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | PFIZER | 2000-04-18 | Yes | Yes | RX | AP |
(NDA) 021131 | 001 | ZYVOX | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 200MG/100ML (2MG/ML) | PFIZER | 2000-04-18 | Yes | No | RX | AP |
(NDA) 021131 | 002 | ZYVOX | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PFIZER | 2000-04-18 | Yes | No | DISCN | |
(NDA) 021130 | 002 | ZYVOX | LINEZOLID | 利奈唑胺 | TABLET;ORAL | 600MG | PFIZER | 2000-04-18 | Yes | Yes | RX | AB |
(NDA) 021130 | 001 | ZYVOX | LINEZOLID | 利奈唑胺 | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PFIZER | 2000-04-18 | Yes | No | DISCN | |
(NDA) 021132 | 001 | ZYVOX | LINEZOLID | 利奈唑胺 | FOR SUSPENSION;ORAL | 100MG/5ML | PFIZER | 2000-04-18 | Yes | Yes | RX | AB |
(NDA) 206473 | 001 | LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | HOSPIRA | 2015-06-18 | Yes | Yes | RX | |
(ANDA) 204764 | 001 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | FRESENIUS KABI USA | 2016-03-15 | No | No | RX | AP |
(ANDA) 200222 | 001 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | TEVA PHARMS | 2012-06-27 | No | No | DISCN | |
(ANDA) 200904 | 002 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | SANDOZ | 2015-07-16 | No | No | RX | AP |
(ANDA) 200904 | 001 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 200MG/100ML (2MG/ML) | SANDOZ | 2015-07-16 | No | No | RX | AP |
(ANDA) 204696 | 002 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | SAGENT PHARMS INC | 2017-03-02 | No | No | RX | AP |
(ANDA) 204696 | 001 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 200MG/100ML (2MG/ML) | SAGENT PHARMS INC | 2017-03-02 | No | No | RX | AP |
(ANDA) 205154 | 002 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | NORVIUM BIOSCIENCE | 2017-12-06 | No | No | RX | AP |
(ANDA) 205154 | 001 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 200MG/100ML (2MG/ML) | NORVIUM BIOSCIENCE | 2017-12-06 | No | No | RX | AP |
(ANDA) 207354 | 001 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 200MG/100ML (2MG/ML) | NANG KUANG PHARM CO | 2016-12-20 | No | No | RX | AP |
(ANDA) 207001 | 002 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | HQ SPCLT PHARMA | 2017-07-07 | No | No | RX | AP |
(ANDA) 207001 | 001 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 200MG/100ML (2MG/ML) | HQ SPCLT PHARMA | 2017-07-07 | No | No | RX | AP |
(ANDA) 205442 | 001 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | HOSPIRA | 2015-07-07 | No | No | DISCN | |
(ANDA) 206454 | 001 | LINEZOLID | LINEZOLID | 利奈唑胺 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | HIKMA | 2022-08-22 | No | No | RX | AP |