美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ABILIFY"
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
ABILIFY 021436 001 NDA ARIPIPRAZOLE TABLET;ORAL 10MG Yes Yes 2002/11/15 2002/11/15 OTSUKA Prescription
ABILIFY 021436 002 NDA ARIPIPRAZOLE TABLET;ORAL 15MG Yes No 2002/11/15 2002/11/15 OTSUKA Prescription
ABILIFY 021436 003 NDA ARIPIPRAZOLE TABLET;ORAL 20MG Yes No 2002/11/15 2002/11/15 OTSUKA Prescription
ABILIFY 021436 004 NDA ARIPIPRAZOLE TABLET;ORAL 30MG Yes No 2002/11/15 2002/11/15 OTSUKA Prescription
ABILIFY 021436 005 NDA ARIPIPRAZOLE TABLET;ORAL 5MG Yes Yes 2002/11/15 2002/11/15 OTSUKA Prescription
ABILIFY 021436 006 NDA ARIPIPRAZOLE TABLET;ORAL 2MG Yes No 2002/11/15 2002/11/15 OTSUKA Prescription
ABILIFY 021713 001 NDA ARIPIPRAZOLE SOLUTION;ORAL 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 2004/12/10 2004/12/10 OTSUKA Discontinued
ABILIFY 021729 002 NDA ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 2006/06/07 2006/06/07 OTSUKA Discontinued
ABILIFY 021729 003 NDA ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 2006/06/07 2006/06/07 OTSUKA Discontinued
ABILIFY 021729 004 NDA ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 2006/06/07 2006/06/07 OTSUKA Discontinued
ABILIFY 021729 005 NDA ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 2006/06/07 2006/06/07 OTSUKA Discontinued
ABILIFY 021866 001 NDA ARIPIPRAZOLE INJECTABLE;INTRAMUSCULAR 9.75MG/1.3ML (7.5MG/ML) No No 2006/09/20 2006/09/20 OTSUKA Discontinued
ABILIFY MAINTENA KIT 202971 001 NDA ARIPIPRAZOLE FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 300MG/VIAL Yes No 2013/02/28 2013/02/28 OTSUKA PHARM CO LTD Prescription
ABILIFY MAINTENA KIT 202971 002 NDA ARIPIPRAZOLE FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 400MG/VIAL Yes Yes 2013/02/28 2013/02/28 OTSUKA PHARM CO LTD Prescription
ABILIFY MAINTENA KIT 202971 003 NDA ARIPIPRAZOLE FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 300MG Yes No 2013/02/28 2014/09/29 OTSUKA PHARM CO LTD Prescription
ABILIFY MAINTENA KIT 202971 004 NDA ARIPIPRAZOLE FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 400MG Yes No 2013/02/28 2014/09/29 OTSUKA PHARM CO LTD Prescription
ABILIFY MYCITE KIT 207202 001 NDA ARIPIPRAZOLE TABLET;ORAL 2MG Yes No 2017/11/13 2017/11/13 OTSUKA PHARM CO LTD Prescription
ABILIFY MYCITE KIT 207202 002 NDA ARIPIPRAZOLE TABLET;ORAL 5MG Yes Yes 2017/11/13 2017/11/13 OTSUKA PHARM CO LTD Prescription
ABILIFY MYCITE KIT 207202 003 NDA ARIPIPRAZOLE TABLET;ORAL 10MG Yes No 2017/11/13 2017/11/13 OTSUKA PHARM CO LTD Prescription
ABILIFY MYCITE KIT 207202 004 NDA ARIPIPRAZOLE TABLET;ORAL 15MG Yes No 2017/11/13 2017/11/13 OTSUKA PHARM CO LTD Prescription
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