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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) 020819 | 001 | ZEMPLAR | PARICALCITOL | 帕立骨化醇 | SOLUTION;INTRAVENOUS | 0.005MG/ML (0.005MG/ML) | ABBVIE | 1998-04-17 | Yes | Yes | RX | AP |
(NDA) 020819 | 003 | ZEMPLAR | PARICALCITOL | 帕立骨化醇 | SOLUTION;INTRAVENOUS | 0.01MG/2ML (0.005MG/ML) | ABBVIE | 2000-02-01 | Yes | Yes | RX | AP |
(NDA) 020819 | 002 | ZEMPLAR | PARICALCITOL | 帕立骨化醇 | SOLUTION;INTRAVENOUS | 0.002MG/ML (0.002MG/ML) | ABBVIE | 2000-02-01 | Yes | Yes | RX | AP |
(NDA) 021606 | 001 | ZEMPLAR | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 1MCG | ABBVIE | 2005-05-26 | Yes | No | RX | AB |
(NDA) 021606 | 002 | ZEMPLAR | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 2MCG | ABBVIE | 2005-05-26 | Yes | No | RX | AB |
(NDA) 021606 | 003 | ZEMPLAR | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ABBVIE | 2005-05-26 | Yes | No | DISCN | |
(ANDA) 091108 | 002 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | SOLUTION;INTRAVENOUS | 0.005MG/ML (0.005MG/ML) | SANDOZ | 2011-07-27 | No | No | RX | AP |
(ANDA) 091108 | 003 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | SOLUTION;INTRAVENOUS | 0.01MG/2ML (0.005MG/ML) | SANDOZ | 2011-07-27 | No | No | RX | AP |
(ANDA) 091108 | 001 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | SOLUTION;INTRAVENOUS | 0.002MG/ML (0.002MG/ML) | SANDOZ | 2011-07-27 | No | No | RX | AP |
(ANDA) 090829 | 001 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 1MCG | TEVA PHARMS USA | 2013-09-27 | No | No | RX | AB |
(ANDA) 090829 | 003 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 4MCG | TEVA PHARMS USA | 2013-09-27 | No | Yes | RX | AB |
(ANDA) 090829 | 002 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 2MCG | TEVA PHARMS USA | 2013-09-27 | No | No | RX | AB |
(ANDA) 202539 | 002 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 2MCG | BIONPHARMA | 2014-03-27 | No | No | RX | AB |
(ANDA) 202539 | 001 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 1MCG | BIONPHARMA | 2014-03-27 | No | No | RX | AB |
(ANDA) 202539 | 003 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 4MCG | BIONPHARMA | 2014-03-27 | No | No | RX | AB |
(ANDA) 202124 | 001 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 1MCG | RISING | 2014-06-24 | No | No | RX | AB |
(ANDA) 202124 | 002 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 2MCG | RISING | 2014-06-24 | No | No | RX | AB |
(ANDA) 091412 | 003 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 4MCG | CHARTWELL RX | 2014-06-24 | No | No | RX | AB |
(ANDA) 091412 | 002 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 2MCG | CHARTWELL RX | 2014-06-24 | No | No | RX | AB |
(ANDA) 091412 | 001 | PARICALCITOL | PARICALCITOL | 帕立骨化醇 | CAPSULE;ORAL | 1MCG | CHARTWELL RX | 2014-06-24 | No | No | RX | AB |