美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=MIRAPEX"
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
MIRAPEX 020667 001 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/07/01 1997/07/01 BOEHRINGER INGELHEIM Discontinued
MIRAPEX 020667 002 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/07/01 1997/07/01 BOEHRINGER INGELHEIM Discontinued
MIRAPEX 020667 003 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/07/01 1997/07/01 BOEHRINGER INGELHEIM Discontinued
MIRAPEX 020667 004 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1.25MG No No 1997/07/01 1997/07/01 BOEHRINGER INGELHEIM Discontinued
MIRAPEX 020667 005 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/07/01 1997/07/01 BOEHRINGER INGELHEIM Discontinued
MIRAPEX 020667 006 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/07/01 1998/02/12 BOEHRINGER INGELHEIM Discontinued
MIRAPEX 020667 007 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/07/01 2007/07/30 BOEHRINGER INGELHEIM Discontinued
MIRAPEX ER 022421 001 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.375MG Yes Yes 2010/02/19 2010/02/19 BOEHRINGER INGELHEIM Prescription
MIRAPEX ER 022421 002 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.75MG Yes No 2010/02/19 2010/02/19 BOEHRINGER INGELHEIM Prescription
MIRAPEX ER 022421 003 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1.5MG Yes No 2010/02/19 2010/02/19 BOEHRINGER INGELHEIM Prescription
MIRAPEX ER 022421 004 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3MG Yes No 2010/02/19 2010/02/19 BOEHRINGER INGELHEIM Prescription
MIRAPEX ER 022421 005 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 4.5MG Yes No 2010/02/19 2010/02/19 BOEHRINGER INGELHEIM Prescription
MIRAPEX ER 022421 006 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2.25MG Yes No 2010/02/19 2011/06/17 BOEHRINGER INGELHEIM Prescription
MIRAPEX ER 022421 007 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3.75MG Yes No 2010/02/19 2011/06/17 BOEHRINGER INGELHEIM Prescription
MIRAPEX ER 022514 001 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 0.375MG No No 2010/03/19 -- BOEHRINGER INGELHEIM Prescription
MIRAPEX ER 022514 002 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 0.75MG No No 2010/03/19 -- BOEHRINGER INGELHEIM Prescription
MIRAPEX ER 022514 003 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 1.5MG No No 2010/03/19 -- BOEHRINGER INGELHEIM Prescription
MIRAPEX ER 022514 004 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 3MG No No 2010/03/19 -- BOEHRINGER INGELHEIM Prescription
MIRAPEX ER 022514 005 NDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 4.5MG No No 2010/03/19 -- BOEHRINGER INGELHEIM Prescription
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