你目前无法使用部分二次筛选功能
请联系客服开通更多权限和功能!
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) 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) 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 |
(ANDA) 219441 | 001 | DIFLUPREDNATE | DIFLUPREDNATE | 二氟泼尼酯 | EMULSION;OPHTHALMIC | 0.05% | CAPLIN | 2024-12-13 | No | No | RX | AB |
(ANDA) 219342 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | EXTROVIS | 2024-11-27 | No | No | RX | AP |
(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 | ||
(NDA) 219293 | 002 | DANZITENP | NILOTINIB TARTRATE | TABLET;ORAL | EQ 95MG BASE | AZURITY | 2024-11-07 | Yes | Yes | RX | ||
(ANDA) 219258 | 001 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 二甲磺酸利右苯丙胺 | TABLET, CHEWABLE;ORAL | 10MG | GRANULES | 2024-12-16 | No | No | RX | AB |
(ANDA) 219258 | 002 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 二甲磺酸利右苯丙胺 | TABLET, CHEWABLE;ORAL | 20MG | GRANULES | 2024-12-16 | No | No | RX | AB |
(ANDA) 219258 | 003 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 二甲磺酸利右苯丙胺 | TABLET, CHEWABLE;ORAL | 30MG | GRANULES | 2024-12-16 | No | No | RX | AB |
(ANDA) 219258 | 004 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 二甲磺酸利右苯丙胺 | TABLET, CHEWABLE;ORAL | 40MG | GRANULES | 2024-12-16 | No | No | RX | AB |
(ANDA) 219258 | 005 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 二甲磺酸利右苯丙胺 | TABLET, CHEWABLE;ORAL | 50MG | GRANULES | 2024-12-16 | No | No | RX | AB |
(ANDA) 219258 | 006 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 二甲磺酸利右苯丙胺 | TABLET, CHEWABLE;ORAL | 60MG | GRANULES | 2024-12-16 | No | No | RX | AB |
(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 |