美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ELAVIL"
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
ELAVIL 012703 001 NDA AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1961/04/07 Approved Prior to Jan 1, 1982 ASTRAZENECA Discontinued
ELAVIL 012703 003 NDA AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1961/04/07 Approved Prior to Jan 1, 1982 ASTRAZENECA Discontinued
ELAVIL 012703 004 NDA AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1961/04/07 Approved Prior to Jan 1, 1982 ASTRAZENECA Discontinued
ELAVIL 012703 005 NDA AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1961/04/07 Approved Prior to Jan 1, 1982 ASTRAZENECA Discontinued
ELAVIL 012703 006 NDA AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1961/04/07 Approved Prior to Jan 1, 1982 ASTRAZENECA Discontinued
ELAVIL 012703 007 NDA AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1961/04/07 Approved Prior to Jan 1, 1982 ASTRAZENECA Discontinued
ELAVIL 012704 001 NDA AMITRIPTYLINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML No No 1961/04/11 Approved Prior to Jan 1, 1982 ASTRAZENECA Discontinued
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