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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) 091195 | 003 | TACROLIMUS | TACROLIMUS | 他克莫司 | CAPSULE;ORAL | EQ 5MG BASE | ACCORD HLTHCARE | 2011-08-31 | No | No | RX | BX |
(NDA) 021438 | 001 | INNOPRAN XL | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | CAPSULE, EXTENDED RELEASE;ORAL | 80MG | ANI PHARMS | 2003-03-12 | Yes | No | RX | BX |
(ANDA) 208833 | 004 | CELECOXIB | CELECOXIB | 塞来昔布 | CAPSULE;ORAL | 400MG | AMNEAL PHARMS | 2018-05-31 | No | No | RX | BX |
(ANDA) 210339 | 003 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 盐酸普罗帕酮 | CAPSULE, EXTENDED RELEASE;ORAL | 425MG | SINOTHERAPEUTICS INC | 2019-01-04 | No | No | RX | BX |
(ANDA) 086457 | 001 | EPIFOAM | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | 醋酸氢化可的松;盐酸普莫卡因 | AEROSOL, METERED;TOPICAL | 1%;1% | MYLAN SPECIALITY LP | 1982-01-01 | No | No | RX | BX |
(ANDA) 091195 | 002 | TACROLIMUS | TACROLIMUS | 他克莫司 | CAPSULE;ORAL | EQ 1MG BASE | ACCORD HLTHCARE | 2011-08-31 | No | No | RX | BX |
(ANDA) 210339 | 002 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 盐酸普罗帕酮 | CAPSULE, EXTENDED RELEASE;ORAL | 325MG | SINOTHERAPEUTICS INC | 2019-01-04 | No | No | RX | BX |
(ANDA) 075953 | 001 | TERCONAZOLE | TERCONAZOLE | 特康唑 | CREAM;VAGINAL | 0.8% | TARO | 2004-04-06 | No | Yes | RX | BX |
(ANDA) 076263 | 001 | DIFLORASONE DIACETATE | DIFLORASONE DIACETATE | 二醋酸二氟拉松 | CREAM;TOPICAL | 0.05% | ANI PHARMS | 2002-12-20 | No | Yes | RX | BX |
(NDA) 021735 | 001 | TERCONAZOLE | TERCONAZOLE | 特康唑 | CREAM;VAGINAL | 0.8% | FOUGERA PHARMS INC | 2004-10-01 | Yes | Yes | RX | BX |
(ANDA) 075508 | 001 | DIFLORASONE DIACETATE | DIFLORASONE DIACETATE | 二醋酸二氟拉松 | CREAM;TOPICAL | 0.05% | TARO | 2000-04-24 | No | Yes | RX | BX |
(ANDA) 208833 | 002 | CELECOXIB | CELECOXIB | 塞来昔布 | CAPSULE;ORAL | 100MG | AMNEAL PHARMS | 2018-05-31 | No | No | RX | BX |
(NDA) 021438 | 002 | INNOPRAN XL | PROPRANOLOL HYDROCHLORIDE | 盐酸普萘洛尔 | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | ANI PHARMS | 2003-03-12 | Yes | Yes | RX | BX |
(ANDA) 086195 | 001 | PROCTOFOAM HC | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | 醋酸氢化可的松;盐酸普莫卡因 | AEROSOL, METERED;TOPICAL | 1%;1% | MYLAN SPECIALITY LP | 1982-01-01 | Yes | Yes | RX | BX |
(ANDA) 210339 | 001 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 盐酸普罗帕酮 | CAPSULE, EXTENDED RELEASE;ORAL | 225MG | SINOTHERAPEUTICS INC | 2019-01-04 | No | No | RX | BX |
(ANDA) 091195 | 001 | TACROLIMUS | TACROLIMUS | 他克莫司 | CAPSULE;ORAL | EQ 0.5MG BASE | ACCORD HLTHCARE | 2011-08-31 | No | No | RX | BX |
(NDA) 050625 | 003 | SANDIMMUNE | CYCLOSPORINE | 环孢素 | CAPSULE;ORAL | 50MG | NOVARTIS | 1992-11-23 | Yes | No | RX | BX |
(ANDA) 208833 | 003 | CELECOXIB | CELECOXIB | 塞来昔布 | CAPSULE;ORAL | 200MG | AMNEAL PHARMS | 2018-05-31 | No | No | RX | BX |
(NDA) 020983 | 001 | VENTOLIN HFA | ALBUTEROL SULFATE | 硫酸沙丁胺醇 | AEROSOL, METERED;INHALATION | EQ 0.09MG BASE/INH | GLAXOSMITHKLINE | 2001-04-19 | Yes | Yes | RX | BX |
(ANDA) 208833 | 001 | CELECOXIB | CELECOXIB | 塞来昔布 | CAPSULE;ORAL | 50MG | AMNEAL PHARMS | 2018-05-31 | No | No | RX | BX |