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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) 218122 | 001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 盐酸洛哌丁胺 | CAPSULE;ORAL | 2MG | AUROBINDO PHARMA LTD | 2023-09-05 | No | No | RX | AB |
(ANDA) 218055 | 001 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 盐酸氟奋乃静 | TABLET;ORAL | 1MG | AUROBINDO PHARMA LTD | 2023-08-18 | No | No | RX | AB |
(ANDA) 218055 | 002 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 盐酸氟奋乃静 | TABLET;ORAL | 2.5MG | AUROBINDO PHARMA LTD | 2023-08-18 | No | No | RX | AB |
(ANDA) 218055 | 003 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 盐酸氟奋乃静 | TABLET;ORAL | 5MG | AUROBINDO PHARMA LTD | 2023-08-18 | No | No | RX | AB |
(ANDA) 218055 | 004 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 盐酸氟奋乃静 | TABLET;ORAL | 10MG | AUROBINDO PHARMA LTD | 2023-08-18 | No | No | RX | AB |
(ANDA) 218036 | 001 | LITHIUM CITRATE | LITHIUM CITRATE | 枸橼酸锂 | SYRUP;ORAL | EQ 300MG CARBONATE/5ML | RUBICON | 2023-08-14 | No | No | RX | AA |
(ANDA) 218012 | 001 | SUNITINIB MALATE | SUNITINIB MALATE | 苹果酸舒尼替尼 | CAPSULE;ORAL | EQ 12.5MG BASE | NOVUGEN | 2023-08-21 | No | No | RX | AB |
(ANDA) 218012 | 002 | SUNITINIB MALATE | SUNITINIB MALATE | 苹果酸舒尼替尼 | CAPSULE;ORAL | EQ 25MG BASE | NOVUGEN | 2023-08-21 | No | No | RX | AB |
(ANDA) 218012 | 003 | SUNITINIB MALATE | SUNITINIB MALATE | 苹果酸舒尼替尼 | CAPSULE;ORAL | EQ 37.5MG BASE | NOVUGEN | 2023-08-21 | No | No | RX | AB |
(ANDA) 218012 | 004 | SUNITINIB MALATE | SUNITINIB MALATE | 苹果酸舒尼替尼 | CAPSULE;ORAL | EQ 50MG BASE | NOVUGEN | 2023-08-21 | No | No | RX | AB |
(ANDA) 217995 | 001 | GABAPENTIN | GABAPENTIN | 加巴喷丁 | TABLET;ORAL | 600MG | RISING | 2023-07-19 | No | No | RX | AB |
(ANDA) 217995 | 002 | GABAPENTIN | GABAPENTIN | 加巴喷丁 | TABLET;ORAL | 800MG | RISING | 2023-07-19 | No | No | RX | AB |
(ANDA) 217975 | 001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | CAPSULE;ORAL | EQ 10MG BASE | UNIQUE PHARM | 2023-08-21 | No | No | RX | AB |
(ANDA) 217975 | 002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | CAPSULE;ORAL | EQ 25MG BASE | UNIQUE PHARM | 2023-08-21 | No | No | RX | AB |
(ANDA) 217975 | 003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | CAPSULE;ORAL | EQ 50MG BASE | UNIQUE PHARM | 2023-08-21 | No | No | RX | AB |
(ANDA) 217975 | 004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | CAPSULE;ORAL | EQ 75MG BASE | UNIQUE PHARM | 2023-08-21 | No | No | RX | AB |
(ANDA) 217975 | 005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | CAPSULE;ORAL | EQ 100MG BASE | UNIQUE PHARM | 2023-08-21 | No | No | RX | AB |
(ANDA) 217916 | 001 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 盐酸双环胺 | TABLET;ORAL | 20MG | BIONPHARMA | 2023-08-04 | No | No | RX | AB |
(ANDA) 217878 | 001 | LEVETIRACETAM | LEVETIRACETAM | 左乙拉西坦 | TABLET;ORAL | 250MG | GRANULES | 2023-06-13 | No | No | RX | AB |
(ANDA) 217878 | 002 | LEVETIRACETAM | LEVETIRACETAM | 左乙拉西坦 | TABLET;ORAL | 500MG | GRANULES | 2023-06-13 | No | No | RX | AB |