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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) 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) 216981 | 001 | PENCICLOVIR | PENCICLOVIR | 喷昔洛韦 | CREAM;TOPICAL | 1% | TORRENT | 2023-08-07 | 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) 091195 | 001 | TACROLIMUS | TACROLIMUS | 他克莫司 | CAPSULE;ORAL | EQ 0.5MG BASE | ACCORD HLTHCARE | 2011-08-31 | No | No | RX | BX |
(ANDA) 210700 | 003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | CAPSULE;ORAL | EQ 50MG BASE | ZYDUS LIFESCIENCES | 2023-03-23 | No | No | RX | BX |
(ANDA) 210700 | 002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | CAPSULE;ORAL | EQ 25MG BASE | ZYDUS LIFESCIENCES | 2023-03-23 | 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) 206770 | 001 | ACYCLOVIR | ACYCLOVIR | 阿昔洛韦 | CREAM;TOPICAL | 5% | ZYDUS LIFESCIENCES | 2023-02-28 | No | No | RX | BX |
(ANDA) 210140 | 001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | CAPSULE;ORAL | EQ 150MG BASE | ZYDUS LIFESCIENCES | 2023-03-21 | No | No | RX | BX |
(ANDA) 213053 | 001 | MUPIROCIN | MUPIROCIN CALCIUM | CREAM;TOPICAL | EQ 2% BASE | ALEMBIC | 2021-11-16 | 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) 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) 091195 | 003 | TACROLIMUS | TACROLIMUS | 他克莫司 | CAPSULE;ORAL | EQ 5MG BASE | ACCORD HLTHCARE | 2011-08-31 | 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 |
(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) 210700 | 004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | CAPSULE;ORAL | EQ 75MG BASE | ZYDUS LIFESCIENCES | 2023-03-23 | No | No | RX | BX |
(ANDA) 217128 | 001 | METRONIDAZOLE | METRONIDAZOLE | 甲硝唑 | CREAM;TOPICAL | 0.75% | ZYDUS LIFESCIENCES | 2023-04-21 | No | No | RX | BX |
(NDA) 050625 | 003 | SANDIMMUNE | CYCLOSPORINE | 环孢素 | CAPSULE;ORAL | 50MG | NOVARTIS | 1992-11-23 | Yes | No | RX | BX |
(ANDA) 210700 | 005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | CAPSULE;ORAL | EQ 100MG BASE | ZYDUS LIFESCIENCES | 2023-03-23 | No | No | RX | BX |
(ANDA) 210700 | 001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | CAPSULE;ORAL | EQ 10MG BASE | ZYDUS LIFESCIENCES | 2023-03-23 | No | No | RX | BX |