美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=SUBSYS"
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
SUBSYS 202788 001 NDA FENTANYL SPRAY;SUBLINGUAL 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2012/01/04 2012/01/04 BTCP PHARMA Discontinued
SUBSYS 202788 002 NDA FENTANYL SPRAY;SUBLINGUAL 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2012/01/04 2012/01/04 BTCP PHARMA Discontinued
SUBSYS 202788 003 NDA FENTANYL SPRAY;SUBLINGUAL 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2012/01/04 2012/01/04 BTCP PHARMA Discontinued
SUBSYS 202788 004 NDA FENTANYL SPRAY;SUBLINGUAL 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2012/01/04 2012/01/04 BTCP PHARMA Discontinued
SUBSYS 202788 005 NDA FENTANYL SPRAY;SUBLINGUAL 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2012/01/04 2012/01/04 BTCP PHARMA Discontinued
SUBSYS 202788 006 NDA FENTANYL SPRAY;SUBLINGUAL 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2012/01/04 2012/08/30 BTCP PHARMA Discontinued
SUBSYS 202788 007 NDA FENTANYL SPRAY;SUBLINGUAL 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2012/01/04 2012/08/30 BTCP PHARMA Discontinued
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