美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ARTANE"
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
ARTANE 006773 003 NDA TRIHEXYPHENIDYL HYDROCHLORIDE TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1949/05/13 Approved Prior to Jan 1, 1982 LEDERLE Discontinued
ARTANE 006773 005 NDA TRIHEXYPHENIDYL HYDROCHLORIDE TABLET;ORAL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1949/05/13 Approved Prior to Jan 1, 1982 LEDERLE Discontinued
ARTANE 006773 009 NDA TRIHEXYPHENIDYL HYDROCHLORIDE ELIXIR;ORAL 2MG/5ML No No 1949/05/13 Approved Prior to Jan 1, 1982 LEDERLE Discontinued
ARTANE 006773 010 NDA TRIHEXYPHENIDYL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG No No 1949/05/13 Approved Prior to Jan 1, 1982 LEDERLE Discontinued
ARTANE 012947 001 NDA TRIHEXYPHENIDYL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG No No 1962/04/18 Approved Prior to Jan 1, 1982 LEDERLE Discontinued
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