美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=DEXEDRINE"
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
DEXEDRINE 083902 001 ANDA DEXTROAMPHETAMINE SULFATE ELIXIR;ORAL 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 1976/02/26 Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE Discontinued
DEXEDRINE 084935 001 ANDA DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG No No 1976/02/26 Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE Discontinued
DEXEDRINE 017078 001 NDA DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG Yes No 1976/08/02 Approved Prior to Jan 1, 1982 IMPAX LABS INC Prescription
DEXEDRINE 017078 002 NDA DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 10MG Yes No 1976/08/02 Approved Prior to Jan 1, 1982 IMPAX LABS INC Prescription
DEXEDRINE 017078 003 NDA DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 15MG Yes Yes 1976/08/02 Approved Prior to Jan 1, 1982 IMPAX LABS INC Prescription
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