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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) 203779 | 001 | AMMONIA N 13 | AMMONIA N-13 | 氨[13N] | INJECTABLE;INTRAVENOUS | 30mCi-300mCi/8ML (3.75-37.5mCi/ML) | 3D IMAGING DRUG | 2015-10-19 | No | No | RX | AP |
(ANDA) 203777 | 001 | SODIUM FLUORIDE F-18 | SODIUM FLUORIDE F-18 | 氟化钠F-18 | INJECTABLE;INTRAVENOUS | 10-200mCi/ML | 3D IMAGING DRUG | 2015-10-19 | No | No | RX | AP |
(ANDA) 203778 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | 3D IMAGING DRUG | 2015-10-30 | No | No | RX | AP |
(NDA) 010375 | 003 | MEDIHALER-ISO | ISOPROTERENOL SULFATE | AEROSOL, METERED;INHALATION | 0.08MG/INH | 3M | 1982-01-01 | No | No | DISCN | ||
(NDA) 012102 | 001 | MEDIHALER ERGOTAMINE | ERGOTAMINE TARTRATE | 酒石酸麦角胺 | AEROSOL, METERED;INHALATION | 0.36MG/INH | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 017027 | 005 | LIPO-HEPIN | HEPARIN SODIUM | 肝素钠 | INJECTABLE;INJECTION | 40,000 UNITS/ML | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 017027 | 009 | LIPO-HEPIN | HEPARIN SODIUM | 肝素钠 | INJECTABLE;INJECTION | 10,000 UNITS/ML | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 017518 | 001 | YTTERBIUM YB 169 DTPA | PENTETATE CALCIUM TRISODIUM YB-169 | 喷替酸钙钠[169Yb] | INJECTABLE;INJECTION | 2mCi/ML | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 010374 | 003 | MEDIHALER-EPI | EPINEPHRINE BITARTRATE | 酒石酸肾上腺素 | AEROSOL, METERED;INHALATION | 0.3MG/INH | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 017027 | 004 | LIPO-HEPIN | HEPARIN SODIUM | 肝素钠 | INJECTABLE;INJECTION | 20,000 UNITS/0.5ML | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 017027 | 002 | LIPO-HEPIN | HEPARIN SODIUM | 肝素钠 | INJECTABLE;INJECTION | 5,000 UNITS/0.5ML | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 010375 | 004 | ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE | 盐酸左异丙肾上腺素 | AEROSOL, METERED;INHALATION | 0.12MG/INH | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 017027 | 010 | LIPO-HEPIN | HEPARIN SODIUM | 肝素钠 | INJECTABLE;INJECTION | 7,500 UNITS/0.5ML | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 017027 | 003 | LIPO-HEPIN | HEPARIN SODIUM | 肝素钠 | INJECTABLE;INJECTION | 10,000 UNITS/0.5ML | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 017027 | 011 | LIPO-HEPIN | HEPARIN SODIUM | 肝素钠 | INJECTABLE;INJECTION | 15,000 UNITS/0.5ML | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 017027 | 001 | LIPO-HEPIN | HEPARIN SODIUM | 肝素钠 | INJECTABLE;INJECTION | 1,000 UNITS/0.5ML | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 017027 | 006 | LIPO-HEPIN | HEPARIN SODIUM | 肝素钠 | INJECTABLE;INJECTION | 1,000 UNITS/ML | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 013296 | 001 | DUO-MEDIHALER | ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE | 盐酸左异丙肾上腺素;重酒石酸去氧肾上腺素 | AEROSOL, METERED;INHALATION | 0.16MG/INH;0.24MG/INH | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 017027 | 008 | LIPO-HEPIN | HEPARIN SODIUM | 肝素钠 | INJECTABLE;INJECTION | 5,000 UNITS/ML | 3M | 1982-01-01 | No | No | DISCN | |
(NDA) 017027 | 007 | LIPO-HEPIN | HEPARIN SODIUM | 肝素钠 | INJECTABLE;INJECTION | 20,000 UNITS/ML | 3M | 1982-01-01 | No | No | DISCN |