药品注册申请号：204506
申请类型：ANDA (仿制药申请)
申请人：WA UNIV SCH MED
申请人全名：WASHINGTON UNIV SCHOOL MEDICINE
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 AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No AP 2014/02/07 2014/02/07 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
2014/02/07 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
无
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
无
与本品治疗等效的药品
活性成分:AMMONIA N-13 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:30mCi-300mCi/8ML (3.75-37.5mCi/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
022119 001 NDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription Yes Yes AP 2007/08/23 FEINSTEIN
203321 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2013/02/25 MCPRF
203700 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2013/02/25 CARDINAL HLTH 414
203812 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2013/06/27 UCLA BIOMEDICAL
203938 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2013/12/09 KREITCHMAN PET CTR
204506 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2014/02/07 WA UNIV SCH MED
204496 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2014/03/28 UCSF RODIOPHARM
204514 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2014/08/19 JOHNS HOPKINS UNIV
204465 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2014/10/23 DECATUR
203783 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2014/10/30 BRIGHAM WOMENS HOSP
204535 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2014/11/20 MIPS CRF
204455 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2015/04/23 NUKEMED
203779 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2015/10/19 3D IMAGING DRUG
204457 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2015/11/18 MIDWEST MEDCL
207025 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2016/02/03 GEN HOSP
209507 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2019/11/01 UNIV TX SW MEDCTR
211740 001 ANDA AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Prescription No No AP 2020/09/09 UNIV WISCONSIN
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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