美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=AMMONIA N 13"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
AMMONIA N 13 022119 001 NDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Yes Yes 2007/08/23 2007/08/23 FEINSTEIN Prescription
AMMONIA N 13 203543 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 3.75-260mCi/ML No No 2012/12/14 2012/12/14 HOUSTON CYCLOTRON Prescription
AMMONIA N 13 203321 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No 2013/02/25 2013/02/25 MCPRF Prescription
AMMONIA N 13 203700 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No 2013/02/25 2013/02/25 CARDINAL HEALTH 414 Prescription
AMMONIA N 13 203812 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No 2013/06/27 2013/06/27 UCLA BIOMEDICAL Prescription
AMMONIA N 13 203938 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No 2013/12/09 2013/12/09 KREITCHMAN PET CTR Prescription
AMMONIA N 13 204506 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No 2014/02/07 2014/02/07 WA UNIV SCH MED Prescription
AMMONIA N 13 204496 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No 2014/03/28 2014/03/28 UCSF RODIOPHARM Prescription
AMMONIA N 13 203933 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No 2014/06/27 2014/06/27 UNIV TX MD ANDERSON Discontinued
AMMONIA N 13 204514 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No 2014/08/19 2014/08/19 JOHNS HOPKINS UNIV Prescription
AMMONIA N 13 204366 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 3.75-260mCi/ML No No 2014/09/19 2014/09/19 SHERTECH LABS LLC Prescription
AMMONIA N 13 204465 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No 2014/10/23 2014/10/23 DECATUR Prescription
AMMONIA N 13 203783 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No 2014/10/30 2014/10/30 BRIGHAM WOMENS HOSP Prescription
AMMONIA N 13 204535 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No 2014/11/20 2014/11/20 MIPS CRF Prescription
AMMONIA N 13 204356 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 3.75-260mCi/ML No No 2014/12/18 2014/12/18 WI MEDCL CYCLOTRON Prescription
AMMONIA N 13 204515 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 3.75-260mCi/mL No No 2015/02/04 2015/02/04 NCM USA BRONX LLC Prescription
AMMONIA N 13 204667 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 18.8mCi-188mCi/5ML (3.75-37.5mCi/ML) No No 2015/04/22 2015/04/22 SOFIE Prescription
AMMONIA N 13 204455 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) No No 2015/04/23 2015/04/23 SPECTRON MRC LLC Prescription
AMMONIA N 13 204352 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 48.75mCi-487.5mCi/13ML (3.75-37.5mCi/ML) No No 2015/05/01 2015/05/01 BIOMEDCL RES FDN Prescription
AMMONIA N 13 204539 001 ANDA AMMONIA N-13 INJECTABLE;INTRAVENOUS 3.75-260mCi/ML No No 2015/06/23 2015/06/23 CENTRAL RADIOPHARM Discontinued
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