药品注册申请号:020379
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER 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
001 CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.01MG/VIAL Yes No AP 1995/07/06 1995/07/06 Prescription
002 CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.02MG/VIAL Yes Yes AP 1995/07/06 Prescription
003 CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.005MG/VIAL Yes No None 1996/06/27 Discontinued
004 CAVERJECT ALPROSTADIL INJECTABLE;INJECTION 0.04MG/VIAL Yes Yes AP 1997/05/19 Prescription
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
2022/12/23 SUPPL-38(补充) Approval Labeling STANDARD
2017/12/06 SUPPL-34(补充) Approval Labeling STANDARD
2017/12/06 SUPPL-32(补充) Approval Labeling STANDARD
2017/12/06 SUPPL-31(补充) Approval Labeling STANDARD
2016/05/05 SUPPL-30(补充) Approval Labeling STANDARD
2016/02/08 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
2014/06/12 SUPPL-28(补充) Approval Labeling STANDARD
2014/06/09 SUPPL-27(补充) Approval Manufacturing (CMC) PRIORITY
2014/03/28 SUPPL-26(补充) Approval Manufacturing (CMC) PRIORITY
2003/09/02 SUPPL-17(补充) Approval Labeling STANDARD
2002/10/15 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
2002/01/15 SUPPL-11(补充) Approval Labeling STANDARD
2001/03/29 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
2000/11/29 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
2000/04/03 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
1999/07/02 SUPPL-12(补充) Approval Labeling STANDARD
1999/01/20 SUPPL-10(补充) Approval Labeling STANDARD
1998/05/20 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1998/03/26 SUPPL-9(补充) Approval Labeling STANDARD
1997/10/08 SUPPL-6(补充) Approval Labeling STANDARD
1997/05/19 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1996/10/21 SUPPL-5(补充) Approval Labeling STANDARD
1996/06/28 SUPPL-4(补充) Approval Labeling STANDARD
1996/06/27 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1996/05/13 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1996/03/19 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY
1995/07/06 ORIG-1(原始申请) Approval Type 3 - New Dosage Form PRIORITY
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
001 5741523 2015/04/21 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5741523 2015/04/21 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5741523 2015/04/21 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5741523 2015/04/21 PDF格式**本条是由Drugfuture回溯的历史信息**
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 PFIZER
020649 002 NDA EDEX ALPROSTADIL INJECTABLE;INJECTION 0.01MG/VIAL Prescription Yes No AP 1997/06/12 ENDO OPERATIONS
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 PFIZER
020649 003 NDA EDEX ALPROSTADIL INJECTABLE;INJECTION 0.02MG/VIAL Prescription Yes No AP 1997/06/12 ENDO OPERATIONS
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 PFIZER
020649 004 NDA EDEX ALPROSTADIL INJECTABLE;INJECTION 0.04MG/VIAL Prescription Yes Yes AP 1997/06/12 ENDO OPERATIONS
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