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| 申请类型 | 申请号 | 药品名称 | 活性成分 | 活性成分中文 | 执行时间 | 持有公司 | 说明书 |
|---|---|---|---|---|---|---|---|
| NDA | 022032 | OMEPRAZOLE | OMEPRAZOLE | 查看 | 2025-10-07 | DEXCEL PHARMA | 查看 |
| BLA | 761444 | BILPREVDA | DENOSUMAB-NXXP | 查看 | 2025-10-07 | SHANGHAI HENLIUS BIOTECH | 查看 |
| BLA | 125289 | SIMPONI | GOLIMUMAB | 查看 | 2025-10-07 | CENTOCOR ORTHO BIOTECH INC | 查看 |
| NDA | 020896 | XELODA | CAPECITABINE | 查看 | 2025-10-06 | CHEPLAPHARM | 查看 |
| NDA | 020273 | DOVONEX | CALCIPOTRIENE | 查看 | 2025-10-06 | LEO PHARMA AS | 查看 |
| NDA | 020554 | DOVONEX | CALCIPOTRIENE | 查看 | 2025-10-06 | LEO PHARMA AS | 查看 |
| NDA | 210661 | AXTLE | PEMETREXED DIPOTASSIUM | 查看 | 2025-10-06 | AVYXA HOLDINGS | 查看 |
| NDA | 215985 | ZORYVE | ROFLUMILAST | 查看 | 2025-10-06 | ARCUTIS | 查看 |
| BLA | 761377 | EYDENZELT | AFLIBERCEPT-BOAV | 查看 | 2025-10-03 | CELLTRION INC | 查看 |
| NDA | 215358 | SCEMBLIX | ASCIMINIB HYDROCHLORIDE | 查看 | 2025-10-03 | NOVARTIS | 查看 |
| BLA | 761034 | TECENTRIQ | ATEZOLIZUMAB | 查看 | 2025-10-03 | GENENTECH INC | 查看 |
| BLA | 761347 | TECENTRIQ HYBREZA | ATEZOLIZUMAB AND HYALURONIDASE-TQJS | 查看 | 2025-10-03 | GENENTECH INC | 查看 |
| BLA | 761342 | TALVEY | TALQUETAMAB-TGVS | 查看 | 2025-10-03 | JANSSEN BIOTECH | 查看 |
| NDA | 214358 | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 查看 | 2025-10-03 | BOEHRINGER INGELHEIM | 查看 |
| NDA | 022512 | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 查看 | 2025-10-03 | BOEHRINGER INGELHEIM | 查看 |
| NDA | 020958 | PEPCID COMPLETE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | 查看 | 2025-10-02 | KENVUE BRANDS | 查看 |
| NDA | 021695 | ANTARA (MICRONIZED) | FENOFIBRATE | 查看 | 2025-10-02 | LUPIN | 查看 |
| NDA | 008943 | DIAMOX | ACETAZOLAMIDE | 查看 | 2025-10-02 | TEVA BRANDED PHARM | 查看 |
| BLA | 125289 | SIMPONI | GOLIMUMAB | 查看 | 2025-10-01 | CENTOCOR ORTHO BIOTECH INC | 查看 |
| NDA | 018927 | TEGRETOL | CARBAMAZEPINE | 查看 | 2025-10-01 | NOVARTIS | 查看 |



