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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) 219342 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | EXTROVIS | 2024-11-27 | No | No | RX | AP |
| (NDA) 219293 | 001 | DANZITENP | NILOTINIB TARTRATE | TABLET;ORAL | EQ 71MG BASE | AZURITY | 2024-11-07 | Yes | No | RX | ||
| (NDA) 219293 | 002 | DANZITENP | NILOTINIB TARTRATE | TABLET;ORAL | EQ 95MG BASE | AZURITY | 2024-11-07 | Yes | Yes | RX | ||
| (ANDA) 219251 | 001 | FLUDROCORTISONE ACETATE | FLUDROCORTISONE ACETATE | 醋酸氟氢可的松 | TABLET;ORAL | 0.1MG | ZYDUS LIFESCIENCES | 2024-10-16 | No | No | RX | AB |
| (NDA) 219249 | 001 | ITOVEBIP | INAVOLISIB | 伊那利塞 | TABLET;ORAL | 3MG | GENENTECH INC | 2024-10-10 | Yes | No | RX | |
| (NDA) 219249 | 002 | ITOVEBIP | INAVOLISIB | 伊那利塞 | TABLET;ORAL | 9MG | GENENTECH INC | 2024-10-10 | Yes | Yes | RX | |
| (ANDA) 219223 | 001 | LORATADINE | LORATADINE | 氯雷他定 | TABLET;ORAL | 10MG | MARKSANS PHARMA | 2024-11-21 | No | No | OTC | |
| (ANDA) 219221 | 001 | IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | 异丙托溴铵 | SPRAY, METERED;NASAL | 0.042MG/SPRAY | RUBICON | 2024-11-15 | No | No | RX | AB |
| (NDA) 219132 | 001 | AQNEURSA | LEVACETYLLEUCINE | FOR SUSPENSION;ORAL | 1GM/PACKET | INTRABIO | 2024-09-24 | Yes | Yes | RX | ||
| (ANDA) 219116 | 001 | BUMETANIDE | BUMETANIDE | 布美他尼 | INJECTABLE;INJECTION | 0.25MG/ML | QILU PHARM HAINAN | 2024-09-19 | No | No | RX | AP |
| (ANDA) 219106 | 001 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | 酒石酸伐尼克兰 | TABLET;ORAL | EQ 0.5MG BASE | INDOCO | 2024-10-29 | No | No | RX | AB |
| (ANDA) 219106 | 002 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | 酒石酸伐尼克兰 | TABLET;ORAL | EQ 1MG BASE | INDOCO | 2024-10-29 | No | No | RX | AB |
| (NDA) 219104 | 001 | PREVYMISP | LETERMOVIR | 来特莫韦 | PELLETS;ORAL | 20MG/PACKET | MSD | 2024-08-30 | Yes | No | RX | |
| (NDA) 219104 | 002 | PREVYMISP | LETERMOVIR | 来特莫韦 | PELLETS;ORAL | 120MG/PACKET | MSD | 2024-08-30 | Yes | Yes | RX | |
| (NDA) 219097 | 001 | IMKELDIP | IMATINIB MESYLATE | 甲磺酸伊马替尼 | SOLUTION;ORAL | EQ 80MG BASE/ML | SHORLA ONCOLOGY | 2024-11-22 | Yes | Yes | RX | |
| (ANDA) 219055 | 001 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 马来酸氟伏沙明 | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | AJANTA PHARMA LTD | 2024-10-17 | No | No | RX | AB |
| (ANDA) 219055 | 002 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 马来酸氟伏沙明 | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | AJANTA PHARMA LTD | 2024-10-17 | No | No | RX | AB |
| (ANDA) 219050 | 001 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | 硫酸麻黄碱 | SOLUTION;INTRAVENOUS | 50MG/ML (50MG/ML) | CAPLIN | 2024-07-18 | No | No | RX | AP |
| (ANDA) 219034 | 001 | PAZOPANIB HYDROCHLORIDE | PAZOPANIB HYDROCHLORIDE | 盐酸培唑帕尼 | TABLET;ORAL | EQ 200MG BASE | EUGIA PHARMA | 2024-12-04 | No | No | RX | AB |
| (ANDA) 219033 | 001 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | 盐酸胍法辛 | TABLET, EXTENDED RELEASE;ORAL | EQ 1MG BASE | UNICHEM | 2024-11-19 | No | No | RX | AB |
