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 083401 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No -- Approved Prior to Jan 1, 1982 WATSON LABS Discontinued
PROMETHAZINE HYDROCHLORIDE 083403 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No -- Approved Prior to Jan 1, 1982 WATSON LABS Discontinued
PROMETHAZINE HYDROCHLORIDE 083532 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No -- Approved Prior to Jan 1, 1982 WATSON LABS Discontinued
PROMETHAZINE HYDROCHLORIDE 083532 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No -- Approved Prior to Jan 1, 1982 WATSON LABS Discontinued
PROMETHAZINE HYDROCHLORIDE 083955 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No -- Approved Prior to Jan 1, 1982 EPIC PHARMA LLC Discontinued
PROMETHAZINE HYDROCHLORIDE 083955 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No -- Approved Prior to Jan 1, 1982 EPIC PHARMA LLC Discontinued
PROMETHAZINE HYDROCHLORIDE 084027 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No -- Approved Prior to Jan 1, 1982 TABLICAPS Discontinued
PROMETHAZINE HYDROCHLORIDE 084080 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No -- Approved Prior to Jan 1, 1982 TABLICAPS Discontinued
PROMETHAZINE HYDROCHLORIDE 084160 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No -- Approved Prior to Jan 1, 1982 ABBOTT Discontinued
PROMETHAZINE HYDROCHLORIDE 084166 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No -- Approved Prior to Jan 1, 1982 ABBOTT Discontinued
PROMETHAZINE HYDROCHLORIDE 084222 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No -- Approved Prior to Jan 1, 1982 ABBOTT Discontinued
PROMETHAZINE HYDROCHLORIDE 084223 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No -- Approved Prior to Jan 1, 1982 ABBOTT Discontinued
PROMETHAZINE HYDROCHLORIDE 084233 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No -- Approved Prior to Jan 1, 1982 INVATECH Discontinued
PROMETHAZINE HYDROCHLORIDE 084539 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No -- Approved Prior to Jan 1, 1982 ABBOTT Discontinued
PROMETHAZINE HYDROCHLORIDE 085664 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No -- Approved Prior to Jan 1, 1982 WATSON LABS Discontinued
PROMETHAZINE HYDROCHLORIDE 085986 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No -- Approved Prior to Jan 1, 1982 WATSON LABS Discontinued
PROMETHAZINE HYDROCHLORIDE 086395 001 ANDA PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML No No -- Approved Prior to Jan 1, 1982 WHITEWORTH TOWN PLSN Discontinued
PROMETHAZINE HYDROCHLORIDE 087518 001 ANDA PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML No No -- Approved Prior to Jan 1, 1982 PHARM ASSOC Discontinued
PROMETHAZINE HYDROCHLORIDE PLAIN 008381 003 NDA PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1952/04/11 Approved Prior to Jan 1, 1982 ANI PHARMS Discontinued
PROMETHAZINE HYDROCHLORIDE PLAIN 008381 004 NDA PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1952/04/11 1984/04/18 ANI PHARMS Discontinued
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