1.本数据库包含了1939年以来美国FDA批准上市的新药、仿制药以及治疗性生物制品的相关信息
2.查询FDA历年批准新分子实体和生物制品，点击 NME和BLA(美国）
查询FDA批准的药物治疗等效性相关信息，点击美国橙皮书
查询FDA生物制品，血液制品等更多详细信息，点击美国紫皮书
3.下载药智数据APP，即可拥有一款专业的移动医药数据搜索引擎
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| 申请号 | 申请类型 | 商品名 | 活性成分 | 中文活性成分 | 剂型/给药途径 | 批准日期 | 申请机构 |
|---|---|---|---|---|---|---|---|
| 761429 | BLA | OPDIVO QVANTIG | NIVOLUMAB;HYALURONIDASE-NVHY | 玻璃酸酶;纳武利尤单抗 | INJECTABLE;INJECTION | 2024-12-27 | BRISTOL-MYERS SQUIBB |
| 761425 | BLA | PYZCHIVA | USTEKINUMAB-TTWE | INJECTABLE;SUBCUTANEOUS | SAMSUNG BIOEPIS CO LTD | ||
| 761420 | BLA | AVTOZMA | TOCILIZUMAB-ANOH | INJECTABLE;INTRAVENOUS | 2025-01-24 | CELLTRION INC | |
| 761417 | BLA | TEVIMBRA | TISLELIZUMAB-JSGR | INJECTABLE;INTRAVENOUS | 2024-12-26 | BEIGENE | |
| 761416 | BLA | ZIIHERA | ZANIDATAMAB-HRII | 泽尼达妥单抗 | INJECTABLE;INJECTION | 2024-11-20 | JAZZ PHARMS |
| 761411 | BLA | NIKTIMVO | axatilimab-csfr | INJECTABLE;INTRAVENOUS | 2024-08-14 | INCYTE CORP | |
| 761406 | BLA | YESINTEK | USTEKINUMAB-KFCE | INJECTABLE;INJECTION | 2024-11-29 | BIOCON BIOLOGICS INC | |
| 761404 | BLA | STOBOCLO | DENOSUMAB-BMWO | INJECTABLE;INJECTION | 2025-02-28 | CELLTRION INC | |
| 761394 | BLA | DATROWAY | DATOPOTAMAB DERUXTECAN-DLNK | INJECTABLE; IV (INFUSION) | 2025-01-17 | DAIICHI SANKYO INC | |
| 761392 | BLA | OSPOMYV | DENOSUMAB-DSSB | INJECTABLE;SUBCUTANEOUS | 2025-02-13 | SAMSUNG BIOEPIS CO LTD | |
| 761391 | BLA | NEMLUVIO | NEMOLIZUMAB-ILTO | INJECTABLE;INJECTION | 2024-12-13 | GALDERMA LABS LP | |
| 761390 | BLA | NEMLUVIO | NEMOLIZUMAB-ILTO | INJECTABLE;INJECTION | 2024-08-12 | GALDERMA LABS LP | |
| 761388 | BLA | PIASKY | CROVALIMAB-AKKZ | INJECTABLE;INTRAVENOUS | 2024-06-20 | GENENTECH INC | |
| 761382 | BLA | ENZEEVU | AFLIBERCEPT-ABZV | INJECTABLE;INJECTION | 2024-08-09 | SANDOZ INC | |
| 761381 | BLA | OPDIVO QVANTIG | NIVOLUMAB;HYALURONIDASE-NVHY | 玻璃酸酶;纳武利尤单抗 | INJECTABLE;SUBCUTANEOUS | 2024-12-27 | BRISTOL-MYERS SQUIBB |
| 761379 | BLA | OTULFI | USTEKINUMAB-AAUZ | INJECTABLE;INJECTION | 2024-09-27 | FRESENIUS KABI USA | |
| 761378 | BLA | AHZANTIVE | AFLIBERCEPT-MRBB | INJECTABLE;INJECTION | 2024-06-28 | FORMYCON AG | |
| 761373 | BLA | PYZCHIVA | USTEKINUMAB-TTWE | INJECTABLE;INJECTION | SAMSUNG BIOEPIS CO LTD | ||
| 761371 | BLA | OCREVUS ZUNOVO | OCRELIZUMAB AND HYALURONIDASE-OCSQ | INJECTABLE;INJECTION | 2024-09-13 | GENENTECH INC | |
| 761369 | BLA | HYMPAVZI | MARSTACIMAB-HNCQ | INJECTABLE;SUBCUTANEOUS | 2024-10-11 | PFIZER INC |
