药品注册申请号:019264
申请类型:NDA (新药申请)
申请人:FRESENIUS KABI USA
申请人全名:FRESENIUS KABI USA 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 PENTAM PENTAMIDINE ISETHIONATE INJECTABLE;INJECTION 300MG/VIAL Yes Yes AP 1984/10/16 1984/10/16 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
2014/01/08 SUPPL-32(补充) Approval Manufacturing (CMC)
2013/02/16 SUPPL-31(补充) Approval Manufacturing (CMC)
2002/05/24 SUPPL-23(补充) Approval Manufacturing (CMC)
1997/10/24 SUPPL-21(补充) Approval Labeling STANDARD
1997/02/26 SUPPL-19(补充) Approval Labeling STANDARD
1996/08/27 SUPPL-15(补充) Approval Labeling
1996/03/18 SUPPL-18(补充) Approval Labeling STANDARD
1994/06/08 SUPPL-17(补充) Approval Manufacturing (CMC)
1994/05/31 SUPPL-16(补充) Approval Manufacturing (CMC)
1993/02/09 SUPPL-13(补充) Approval Labeling
1989/08/16 SUPPL-14(补充) Approval Manufacturing (CMC)
1988/11/14 SUPPL-12(补充) Approval Manufacturing (CMC)
1987/06/12 SUPPL-8(补充) Approval Manufacturing (CMC)
1987/06/10 SUPPL-3(补充) Approval Manufacturing (CMC)
1987/04/09 SUPPL-4(补充) Approval Labeling
1986/10/24 SUPPL-7(补充) Approval Manufacturing (CMC)
1986/10/24 SUPPL-6(补充) Approval Manufacturing (CMC)
1986/10/24 SUPPL-5(补充) Approval Manufacturing (CMC)
1985/08/06 SUPPL-2(补充) Approval Manufacturing (CMC)
1984/10/16 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY ;Orphan
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:PENTAMIDINE ISETHIONATE 剂型/给药途径:INJECTABLE;INJECTION 规格:300MG/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
019264 001 NDA PENTAM PENTAMIDINE ISETHIONATE INJECTABLE;INJECTION 300MG/VIAL Prescription Yes Yes AP 1984/10/16 FRESENIUS KABI USA
206666 001 ANDA PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE INJECTABLE;INJECTION 300MG/VIAL Prescription No No AP 2017/09/28 SETON PHARMS
213806 001 ANDA PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE INJECTABLE;INJECTION 300MG/VIAL Prescription No No AP 2021/01/07 AVET LIFESCIENCES
206982 001 ANDA PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE INJECTABLE;INJECTION 300MG/VIAL Prescription No No AP 2022/03/17 XGEN PHARMS
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