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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) 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 | ITOVEBI | INAVOLISIB | 伊那利塞 | TABLET;ORAL | 3MG | GENENTECH INC | 2024-10-10 | Yes | No | RX | |
| (NDA) 219249 | 002 | ITOVEBI | INAVOLISIB | 伊那利塞 | TABLET;ORAL | 9MG | GENENTECH INC | 2024-10-10 | Yes | Yes | RX | |
| (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 | |
| (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 |
| (NDA) 219016 | 001 | EDURANT PEDP | RILPIVIRINE HYDROCHLORIDE | 利匹韦林 | TABLET, FOR SUSPENSION;ORAL | EQ 2.5MG BASE | JANSSEN PRODS | 2024-03-15 | Yes | No | DISCN | |
| (NDA) 219008 | 001 | LAZCLUZEP | LAZERTINIB MESYLATE | 甲磺酸兰泽替尼 | TABLET;ORAL | EQ 80MG BASE | JANSSEN BIOTECH | 2024-08-19 | Yes | No | RX | |
| (NDA) 219008 | 002 | LAZCLUZEP | LAZERTINIB MESYLATE | 甲磺酸兰泽替尼 | TABLET;ORAL | EQ 240MG BASE | JANSSEN BIOTECH | 2024-08-19 | Yes | Yes | RX | |
| (ANDA) 219002 | 001 | TRAMETINIB DIMETHYL SULFOXIDE | TRAMETINIB DIMETHYL SULFOXIDE | 曲美替尼二甲亚砜 | TABLET;ORAL | EQ 0.5MG | NOVUGEN | 2024-08-06 | No | No | DISCN | |
| (ANDA) 219002 | 002 | TRAMETINIB DIMETHYL SULFOXIDE | TRAMETINIB DIMETHYL SULFOXIDE | 曲美替尼二甲亚砜 | TABLET;ORAL | EQ 2MG | NOVUGEN | 2024-08-06 | No | No | DISCN | |
| (ANDA) 218993 | 001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 咪达唑仑 | SOLUTION;INTRAVENOUS | 50MG/50ML (1MG/ML) | GLAND PHARMA LTD | 2024-08-12 | No | No | RX | AP |
| (ANDA) 218993 | 002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 咪达唑仑 | SOLUTION;INTRAVENOUS | 100MG/100ML (1MG/ML) | GLAND PHARMA LTD | 2024-08-12 | No | No | RX | AP |
| (ANDA) 218991 | 001 | VALSARTAN | VALSARTAN | 缬沙坦 | TABLET;ORAL | 40MG | ZYDUS LIFESCIENCES | 2024-07-22 | No | No | RX | AB |
