美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=SOTRADECOL"
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
SOTRADECOL 005970 004 NDA SODIUM TETRADECYL SULFATE INJECTABLE;INJECTION 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1946/08/13 Approved Prior to Jan 1, 1982 ELKINS SINN Discontinued
SOTRADECOL 005970 005 NDA SODIUM TETRADECYL SULFATE INJECTABLE;INJECTION 3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1946/08/13 Approved Prior to Jan 1, 1982 ELKINS SINN Discontinued
SOTRADECOL 040541 001 ANDA SODIUM TETRADECYL SULFATE INJECTABLE;INJECTION 20MG/2ML (10MG/ML) No Yes 2004/11/12 2004/11/12 MYLAN INSTITUTIONAL Prescription
SOTRADECOL 040541 002 ANDA SODIUM TETRADECYL SULFATE INJECTABLE;INJECTION 60MG/2ML (30MG/ML) No Yes 2004/11/12 2004/11/12 MYLAN INSTITUTIONAL Prescription
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