药品注册申请号:020649
申请类型:NDA (新药申请)
申请人:AUXILIUM PHARMS LLC
申请人全名:AUXILIUM PHARMACEUTICALS LLC
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
001 EDEX ALPROSTADIL INJECTABLE;INJECTION 0.005MG/VIAL No No None 1997/06/12 1997/06/12 Discontinued
002 EDEX ALPROSTADIL INJECTABLE;INJECTION 0.01MG/VIAL Yes No AP 1997/06/12 Prescription
003 EDEX ALPROSTADIL INJECTABLE;INJECTION 0.02MG/VIAL Yes No AP 1997/06/12 Prescription
004 EDEX ALPROSTADIL INJECTABLE;INJECTION 0.04MG/VIAL Yes Yes AP 1997/06/12 Prescription
005 EDEX ALPROSTADIL INJECTABLE;INJECTION 0.01MG/VIAL Yes Yes None 1998/07/30 Prescription
006 EDEX ALPROSTADIL INJECTABLE;INJECTION 0.02MG/VIAL Yes Yes None 1998/07/30 Prescription
007 EDEX ALPROSTADIL INJECTABLE;INJECTION 0.04MG/VIAL Yes Yes None 1998/07/30 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/11/17 SUPPL 24 Approval Manufacturing (CMC) STANDARD
2015/03/09 SUPPL 23 Approval Labeling STANDARD
2014/03/12 SUPPL 22 Approval Manufacturing (CMC) STANDARD
2014/02/11 SUPPL 21 Approval Manufacturing (CMC) STANDARD
2006/06/09 SUPPL 15 Approval Labeling STANDARD
2001/12/14 SUPPL 13 Approval Manufacturing (CMC) STANDARD
2000/07/31 SUPPL 11 Approval Manufacturing (CMC) STANDARD
2000/06/01 SUPPL 12 Approval Manufacturing (CMC) STANDARD
2000/03/10 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1999/11/19 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1999/10/20 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1999/10/20 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1999/10/15 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1999/09/06 SUPPL 9 Approval Labeling STANDARD
1998/09/22 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1998/07/30 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1998/04/01 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1997/11/05 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1997/06/12 ORIG 1 Approval Type 3 - New Dosage Form 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:ALPROSTADIL 剂型/给药途径:INJECTABLE;INJECTION 规格:0.01MG/VIAL 治疗等效代码:AP
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
020379 001 NDA CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.01MG/VIAL Prescription Yes No AP 1995/07/06 PHARMACIA AND UPJOHN
020649 002 NDA EDEX ALPROSTADIL INJECTABLE;INJECTION 0.01MG/VIAL Prescription Yes No AP 1997/06/12 AUXILIUM PHARMS LLC
活性成分:ALPROSTADIL 剂型/给药途径:INJECTABLE;INJECTION 规格:0.02MG/VIAL 治疗等效代码:AP
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
020379 002 NDA CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.02MG/VIAL Prescription Yes Yes AP 1995/07/06 PHARMACIA AND UPJOHN
020649 003 NDA EDEX ALPROSTADIL INJECTABLE;INJECTION 0.02MG/VIAL Prescription Yes No AP 1997/06/12 AUXILIUM PHARMS LLC
活性成分:ALPROSTADIL 剂型/给药途径:INJECTABLE;INJECTION 规格:0.04MG/VIAL 治疗等效代码:AP
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
020379 004 NDA CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.04MG/VIAL Prescription Yes Yes AP 1997/05/19 PHARMACIA AND UPJOHN
020649 004 NDA EDEX ALPROSTADIL INJECTABLE;INJECTION 0.04MG/VIAL Prescription Yes Yes AP 1997/06/12 AUXILIUM PHARMS LLC
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