美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=PHENERGAN"
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
PHENERGAN 007935 002 NDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1951/03/29 Approved Prior to Jan 1, 1982 DELCOR ASSET CORP Discontinued
PHENERGAN 007935 003 NDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1951/03/29 Approved Prior to Jan 1, 1982 DELCOR ASSET CORP Discontinued
PHENERGAN 007935 004 NDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1951/03/29 Approved Prior to Jan 1, 1982 DELCOR ASSET CORP Discontinued
PHENERGAN W/ CODEINE 008306 004 NDA CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1952/01/21 1984/04/02 ANI PHARMS Discontinued
PHENERGAN VC W/ CODEINE 008306 005 NDA CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1952/01/21 1984/04/02 ANI PHARMS Discontinued
PHENERGAN VC 008604 003 NDA PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1954/09/14 1984/04/02 ANI PHARMS Discontinued
PHENERGAN 008857 002 NDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 1956/08/20 Approved Prior to Jan 1, 1982 WYETH AYERST Discontinued
PHENERGAN 008857 003 NDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No 1956/08/20 Approved Prior to Jan 1, 1982 WYETH AYERST Discontinued
PHENERGAN 010926 001 NDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1958/05/05 Approved Prior to Jan 1, 1982 NORVIUM BIOSCIENCE Discontinued
PHENERGAN 010926 002 NDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1958/05/05 Approved Prior to Jan 1, 1982 NORVIUM BIOSCIENCE Discontinued
PHENERGAN 011689 001 NDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1960/04/27 Approved Prior to Jan 1, 1982 NORVIUM BIOSCIENCE Discontinued
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