药品注册申请号:203935
申请类型:ANDA (仿制药申请)
申请人:WUSM CYCLOTRON
申请人全名:WASHINGTON UNIV SCH MEDICINE CYCLOTRON FACILITY
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML No No AP 2014/02/05 2014/02/05 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2020/01/03 SUPPL-5(补充) Approval Labeling STANDARD
2014/02/05 ORIG-1(原始申请) Approval
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
活性成分:FLUDEOXYGLUCOSE F-18 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:20-300mCi/ML 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
203246 002 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2014/01/13 UNIV TX MD ANDERSON
203935 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2014/02/05 WUSM CYCLOTRON
203946 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Discontinued No No AP 2014/02/05 ESSENTIAL ISOTOPES
203902 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2014/05/09 UCSF RODIOPHARM
203990 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2014/08/06 UIHC PET IMAGING
204333 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2014/09/25 MA GENERAL HOSP
204463 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2014/10/21 DECATUR
204385 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2014/10/29 CHILDRENS HOSP MI
204525 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2014/10/29 ISOLOGIC INNOVATIVE
203816 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2014/10/30 BRIGHAM WOMENS
204264 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2014/12/18 PHARMALOGIC
204512 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2015/01/07 NCM USA BRONX LLC
203904 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2015/04/23 METHODIST HOSP RES
203837 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2015/05/01 BIOMEDCL RES FDN
203710 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2015/05/01 BIOMEDCL RES FDN
203920 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2015/06/23 JUBILANT DRAXIMAGE
204498 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2015/06/23 UNIV UTAH CYCLOTRON
204531 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2015/07/17 UNIV MICHIGAN
203591 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2015/08/31 SOFIE
204472 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2015/09/11 MIPS CRF
203778 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2015/10/30 3D IMAGING DRUG
203603 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2015/11/13 CARDINAL HEALTH 414
208679 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2016/12/08 MEM SLOAN-KETTERING
209341 001 ANDA FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML Prescription No No AP 2020/12/16 UNIV SOUTHERN CA
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