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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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(ANDA) 212411 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | SINOTHERAPEUTICS INC | 2019-08-21 | No | No | RX | AB |
(ANDA) 213454 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | AET PHARMA | 2021-02-01 | No | Yes | RX | AB |
(ANDA) 216626 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | AMNEAL | 2022-12-22 | No | No | RX | AB |
(ANDA) 217119 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | AUROBINDO PHARMA | 2024-07-18 | No | No | RX | AB |
(ANDA) 214476 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | BIOCON PHARMA | 2022-02-04 | No | No | RX | AB |
(ANDA) 212500 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | DR REDDYS | 2022-04-07 | No | No | RX | AB |
(ANDA) 214321 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | HETERO LABS LTD III | 2022-12-08 | No | No | RX | AB |
(ANDA) 216488 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | I 3 PHARMS | 2023-08-28 | No | No | RX | AB |
(ANDA) 218434 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | MSN | 2025-02-24 | No | No | RX | AB |
(ANDA) 207355 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | ACTAVIS LABS FL INC | 2022-11-30 | No | No | DISCN | |
(NDA) 205053 | 001 | NOXAFIL | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | MERCK SHARP DOHME | 2013-11-25 | Yes | No | DISCN | |
(ANDA) 217720 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | QILU PHARM HAINAN | 2025-04-23 | No | No | RX | AB |
(ANDA) 212226 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | SPECGX LLC | 2022-05-10 | No | No | RX | AB |
(ANDA) 216326 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | TABLET, DELAYED RELEASE;ORAL | 100MG | WESTMINSTER PHARMS | 2023-06-20 | No | No | RX | AB |
(ANDA) 208773 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | SUSPENSION;ORAL | 40MG/ML | HIKMA | 2020-05-15 | No | No | RX | AB |
(NDA) 022003 | 001 | NOXAFIL | POSACONAZOLE | 泊沙康唑 | SUSPENSION;ORAL | 40MG/ML | SCHERING | 2006-09-15 | Yes | Yes | RX | AB |
(ANDA) 209983 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | SOLUTION;INTRAVENOUS | 300MG/16.7ML (18MG/ML) | FRESENIUS KABI USA | 2023-12-26 | No | No | RX | AP |
(ANDA) 217553 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | SOLUTION;INTRAVENOUS | 300MG/16.7ML (18MG/ML) | GLAND | 2023-12-26 | No | No | RX | AP |
(ANDA) 211500 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | SOLUTION;INTRAVENOUS | 300MG/16.7ML (18MG/ML) | MYLAN LABS LTD | 2023-12-26 | No | No | RX | AP |
(ANDA) 219057 | 001 | POSACONAZOLE | POSACONAZOLE | 泊沙康唑 | SOLUTION;INTRAVENOUS | 300MG/16.7ML (18MG/ML) | ASPIRO | 2024-12-23 | No | No | RX | AP |