美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=PROMETHAZINE HYDROCHLORIDE"
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
PROMETHAZINE HYDROCHLORIDE 040737 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No 2008/04/24 2008/04/24 XGEN PHARMS Prescription
PROMETHAZINE HYDROCHLORIDE 040791 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No 2008/05/20 2008/05/20 IMPAX LABS Discontinued
PROMETHAZINE HYDROCHLORIDE 040791 002 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No 2008/05/20 2008/02/12 IMPAX LABS Discontinued
PROMETHAZINE HYDROCHLORIDE 040791 003 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No 2008/05/20 2008/02/12 IMPAX LABS Discontinued
PROMETHAZINE HYDROCHLORIDE 040785 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2008/09/26 2008/09/26 WOCKHARDT Discontinued
PROMETHAZINE HYDROCHLORIDE 040785 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No 2008/09/26 2008/09/26 WOCKHARDT Discontinued
PROMETHAZINE HYDROCHLORIDE 040863 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No 2008/12/30 2008/12/30 SUN PHARM INDS INC Discontinued
PROMETHAZINE HYDROCHLORIDE 040863 002 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No 2008/12/30 2008/12/30 SUN PHARM INDS INC Discontinued
PROMETHAZINE HYDROCHLORIDE 040863 003 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No 2008/12/30 2008/12/30 SUN PHARM INDS INC Discontinued
PROMETHAZINE HYDROCHLORIDE 040891 001 ANDA PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML No No 2009/03/13 2009/03/13 NOSTRUM LABS INC Prescription
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE 040902 001 ANDA PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 5MG/5ML;6.25MG/5ML No No 2009/08/25 2009/08/25 AMNEAL PHARMS Prescription
PROMETHAZINE HYDROCHLORIDE 040882 001 ANDA PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML No No 2009/12/30 2009/12/30 AMNEAL PHARMS Discontinued
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 090180 001 ANDA CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML No No 2010/03/17 2010/03/17 NOSTRUM LABS INC Prescription
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 090180 002 ANDA PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE SYRUP; ORAL 10MG; 5ML No No 2010/03/17 -- NOSTRUM LABS INC Prescription
PROMETHAZINE HYDROCHLORIDE 091179 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No 2010/12/13 2010/12/13 AMNEAL PHARMS NY Prescription
PROMETHAZINE HYDROCHLORIDE 091179 002 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No 2010/12/13 2010/12/13 AMNEAL PHARMS NY Prescription
PROMETHAZINE HYDROCHLORIDE 091179 003 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No 2010/12/13 2010/12/13 AMNEAL PHARMS NY Prescription
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 090575 001 ANDA DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 15MG/5ML;6.25MG/5ML No No 2011/02/08 2011/02/08 AMNEAL PHARMS Prescription
PROMETHAZINE HYDROCHLORIDE 091054 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No 2011/08/30 2011/08/30 AUROBINDO PHARMA USA Discontinued
PROMETHAZINE HYDROCHLORIDE 091054 002 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No 2011/08/30 2011/08/30 AUROBINDO PHARMA USA Discontinued
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