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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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(NDA) 021870 | 002 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-400mCi/ML | FEINSTEIN | 2008-11-21 | Yes | Yes | RX | AP |
(ANDA) 203612 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-240mCi/ML | MCPRF | 2013-08-05 | No | No | RX | AP |
(ANDA) 204525 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | ISOLOGIC INNOVATIVE | 2014-10-29 | No | No | RX | AP |
(ANDA) 203946 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | ESSENTIAL ISOTOPES | 2014-02-05 | No | No | DISCN | |
(ANDA) 203710 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | BIOMEDCL RES FDN | 2015-05-01 | No | No | RX | AP |
(ANDA) 203837 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | BIOMEDCL RES FDN | 2015-05-01 | No | No | RX | AP |
(ANDA) 216125 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-400mCi/ML | BAMF | 2025-03-11 | 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 |
(ANDA) 204385 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | CHILDRENS HOSP MI | 2014-10-29 | No | No | RX | AP |
(ANDA) 204759 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 4-40mCi/ML | KETTERING MEDCTR | 2015-10-27 | No | No | RX | AP |
(ANDA) 203603 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | CARDINAL HEALTH 414 | 2015-11-13 | No | No | RX | AP |
(ANDA) 203603 | 002 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-500mCi/ML | CARDINAL HEALTH 414 | 2018-09-27 | No | Yes | RX | AP |
(NDA) 020306 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INJECTION | 4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | DOWNSTATE CLINCL | 1994-08-19 | Yes | No | DISCN | |
(ANDA) 203937 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 4-500mCi/ML | HOT SHOTS NM LLC | 2014-10-30 | No | No | DISCN | |
(ANDA) 203920 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | JUBILANT DRAXIMAGE | 2015-06-23 | No | No | RX | AP |
(ANDA) 203942 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 10-100mCi/ML | KREITCHMAN PET CTR | 2016-04-11 | No | No | RX | AP |
(ANDA) 203816 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | BRIGHAM WOMENS | 2014-10-30 | No | No | RX | AP |
(ANDA) 204333 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | MA GENERAL HOSP | 2014-09-25 | No | No | RX | AP |
(NDA) 021870 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FEINSTEIN | 2005-08-19 | Yes | No | DISCN | |
(NDA) 020306 | 002 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INJECTION | 4-90mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | DOWNSTATE CLINCL | 2001-09-25 | Yes | No | DISCN |