1. 列表页商品名字段中有红色标记P代表该数据有专利信息；当使用各个专利到期时间检索条件时，“有无专利”默认为有。
2. 批准日期显示1982-01-01的，实际为1982-01-01之前。
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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) 219661 | 001 | METHENAMINE HIPPURATE | METHENAMINE HIPPURATE | 马尿酸乌洛托品 | TABLET;ORAL | 1GM | ZYDUS LIFESCIENCES | 2025-03-10 | No | No | RX | AB |
| (ANDA) 219562 | 001 | LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 左乙拉西坦 | INJECTABLE;INTRAVENOUS | 500MG/100ML (5MG/ML) | CAPLIN | 2025-01-16 | No | No | RX | AP |
| (ANDA) 219562 | 002 | LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 左乙拉西坦 | INJECTABLE;INTRAVENOUS | 1GM/100ML (10MG/ML) | CAPLIN | 2025-01-16 | No | No | RX | AP |
| (ANDA) 219562 | 003 | LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 左乙拉西坦 | INJECTABLE;INTRAVENOUS | 1.5GM/100ML (15MG/ML) | CAPLIN | 2025-01-16 | No | No | RX | AP |
| (ANDA) 219557 | 001 | OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | 盐酸奥洛他定 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.2% BASE | GLENMARK PHARMS INC | 2025-02-28 | No | No | OTC | |
| (ANDA) 219547 | 001 | SELENIOUS ACID | SELENIOUS ACID | SOLUTION;INTRAVENOUS | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SUN PHARM | 2025-02-20 | No | No | RX | AP | |
| (ANDA) 219494 | 001 | SPIRONOLACTONE | SPIRONOLACTONE | 螺内酯 | TABLET;ORAL | 25MG | GRAVITI PHARMS | 2025-01-23 | No | No | RX | AB |
| (ANDA) 219494 | 002 | SPIRONOLACTONE | SPIRONOLACTONE | 螺内酯 | TABLET;ORAL | 50MG | GRAVITI PHARMS | 2025-01-23 | No | No | RX | AB |
| (ANDA) 219494 | 003 | SPIRONOLACTONE | SPIRONOLACTONE | 螺内酯 | TABLET;ORAL | 100MG | GRAVITI PHARMS | 2025-01-23 | No | No | RX | AB |
| (NDA) 219488 | 001 | CTEXLI | CHENODIOL | 鹅去氧胆酸 | TABLET;ORAL | 250MG | MIRUM | 2025-02-21 | Yes | Yes | RX | |
| (ANDA) 219441 | 001 | DIFLUPREDNATE | DIFLUPREDNATE | 二氟泼尼酯 | EMULSION;OPHTHALMIC | 0.05% | CAPLIN | 2024-12-13 | No | No | RX | AB |
| (NDA) 219389 | 001 | GOMEKLIP | MIRDAMETINIB | 莫达美替尼 | CAPSULE;ORAL | 1MG | SPRINGWORKS | 2025-02-11 | Yes | No | RX | |
| (NDA) 219389 | 002 | GOMEKLIP | MIRDAMETINIB | 莫达美替尼 | CAPSULE;ORAL | 2MG | SPRINGWORKS | 2025-02-11 | Yes | Yes | RX | |
| (NDA) 219379 | 001 | GOMEKLIP | MIRDAMETINIB | 莫达美替尼 | TABLET, FOR SUSPENSION;ORAL | 1MG | SPRINGWORKS | 2025-02-11 | Yes | Yes | RX | |
| (ANDA) 219342 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | EXTROVIS | 2024-11-27 | No | No | RX | AP |
| (NDA) 219304 | 001 | ROMVIMZAP | VIMSELTINIB | 维塞替尼 | CAPSULE;ORAL | 14MG | DECIPHERA PHARMS | 2025-02-14 | Yes | No | RX | |
| (NDA) 219304 | 002 | ROMVIMZAP | VIMSELTINIB | 维塞替尼 | CAPSULE;ORAL | 20MG | DECIPHERA PHARMS | 2025-02-14 | Yes | No | RX | |
| (NDA) 219304 | 003 | ROMVIMZAP | VIMSELTINIB | 维塞替尼 | CAPSULE;ORAL | 30MG | DECIPHERA PHARMS | 2025-02-14 | Yes | Yes | RX | |
| (ANDA) 219302 | 001 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | 盐酸丁丙诺啡 | INJECTABLE;INJECTION | EQ 0.3MG BASE/ML | SOMERSET THERAPS LLC | 2025-01-30 | No | No | RX | AP |
| (NDA) 219293 | 001 | DANZITENP | NILOTINIB TARTRATE | TABLET;ORAL | EQ 71MG BASE | AZURITY | 2024-11-07 | Yes | No | RX |
