药品注册申请号:012836
申请类型:NDA (新药申请)
申请人:BOEHRINGER INGELHEIM
申请人全名:BOEHRINGER INGELHEIM PHARMACEUTICALS INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
003 PERSANTINE DIPYRIDAMOLE TABLET;ORAL 25MG Yes No AB 1961/12/06 1986/12/22 Discontinued
004 PERSANTINE DIPYRIDAMOLE TABLET;ORAL 50MG Yes No AB 1987/02/06 Discontinued
005 PERSANTINE DIPYRIDAMOLE TABLET;ORAL 75MG Yes No AB 1987/02/06 Discontinued
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2019/12/11 SUPPL-61(补充) Approval Labeling STANDARD
2015/07/29 SUPPL-60(补充) Approval Manufacturing (CMC) STANDARD
2014/05/08 SUPPL-59(补充) Approval Manufacturing (CMC) STANDARD
2005/08/01 SUPPL-57(补充) Approval Labeling STANDARD
2004/08/05 SUPPL-54(补充) Approval Labeling STANDARD
2002/06/20 SUPPL-56(补充) Approval Manufacturing (CMC) STANDARD
2002/02/08 SUPPL-55(补充) Approval Manufacturing (CMC) STANDARD
2001/05/24 SUPPL-53(补充) Approval Manufacturing (CMC) STANDARD
2000/02/08 SUPPL-52(补充) Approval Manufacturing (CMC) STANDARD
1997/07/03 SUPPL-51(补充) Approval Labeling STANDARD
1995/02/21 SUPPL-46(补充) Approval Manufacturing (CMC) STANDARD
1994/05/18 SUPPL-50(补充) Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL-49(补充) Approval Labeling STANDARD
1991/03/26 SUPPL-47(补充) Approval Labeling
1989/08/30 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1988/12/12 SUPPL-42(补充) Approval Manufacturing (CMC) STANDARD
1988/11/08 SUPPL-45(补充) Approval Labeling
1988/02/24 SUPPL-41(补充) Approval Labeling
1987/02/06 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1986/12/22 SUPPL-38(补充) Approval Labeling
1986/12/22 SUPPL-14(补充) Approval Efficacy
1982/10/08 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1961/12/06 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
活性成分:DIPYRIDAMOLE 剂型/给药途径:TABLET;ORAL 规格:25MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
012836 003 NDA PERSANTINE DIPYRIDAMOLE TABLET;ORAL 25MG Discontinued Yes No AB 1986/12/22 BOEHRINGER INGELHEIM
087184 001 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 25MG Prescription No No AB 1990/10/03 BARR
086944 002 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 25MG Discontinued No No AB 1991/04/16 ANI PHARMS
040542 001 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 25MG Prescription No No AB 2006/04/21 OXFORD PHARMS
040733 001 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 25MG Prescription No No AB 2007/02/13 RISING
040782 001 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 25MG Prescription No No AB 2007/07/18 IMPAX LABS
040874 001 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 25MG Prescription No No AB 2008/01/28 ZYDUS PHARMS USA INC
活性成分:DIPYRIDAMOLE 剂型/给药途径:TABLET;ORAL 规格:50MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
012836 004 NDA PERSANTINE DIPYRIDAMOLE TABLET;ORAL 50MG Discontinued Yes No AB 1987/02/06 BOEHRINGER INGELHEIM
087716 001 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 50MG Prescription No No AB 1990/10/03 BARR
086944 001 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 50MG Discontinued No No AB 1992/02/25 ANI PHARMS
040542 002 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 50MG Prescription No No AB 2006/04/21 OXFORD PHARMS
040733 002 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 50MG Prescription No No AB 2007/02/13 RISING
040782 002 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 50MG Prescription No No AB 2007/07/18 IMPAX LABS
040874 002 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 50MG Prescription No No AB 2008/01/28 ZYDUS PHARMS USA INC
活性成分:DIPYRIDAMOLE 剂型/给药途径:TABLET;ORAL 规格:75MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
012836 005 NDA PERSANTINE DIPYRIDAMOLE TABLET;ORAL 75MG Discontinued Yes No AB 1987/02/06 BOEHRINGER INGELHEIM
087717 001 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 75MG Prescription No No AB 1990/10/03 BARR
086944 003 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 75MG Discontinued No No AB 1992/02/25 ANI PHARMS
040542 003 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 75MG Prescription No No AB 2006/04/21 OXFORD PHARMS
040733 003 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 75MG Prescription No No AB 2007/02/13 RISING
040782 003 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 75MG Prescription No Yes AB 2007/07/18 IMPAX LABS
040874 003 ANDA DIPYRIDAMOLE DIPYRIDAMOLE TABLET;ORAL 75MG Prescription No No AB 2008/01/28 ZYDUS PHARMS USA INC
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