药品注册申请号:050108
申请类型:NDA (新药申请)
申请人:ENDO OPERATIONS
申请人全名:ENDO OPERATIONS LTD
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
002 COLY-MYCIN M COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL Yes Yes AP 1970/06/04 Approved Prior to Jan 1, 1982 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
2017/04/14 SUPPL-33(补充) Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2013/03/07 SUPPL-30(补充) Approval Labeling STANDARD
2009/05/13 SUPPL-26(补充) Approval Labeling STANDARD
2006/01/12 SUPPL-24(补充) Approval Labeling STANDARD
2002/12/20 SUPPL-23(补充) Approval Labeling STANDARD
2001/09/28 SUPPL-22(补充) Approval Manufacturing (CMC)
1999/11/26 SUPPL-21(补充) Approval Labeling STANDARD
1994/04/28 SUPPL-20(补充) Approval Manufacturing (CMC)
1985/12/10 SUPPL-4(补充) Approval Manufacturing (CMC)
1983/04/11 SUPPL-3(补充) Approval Manufacturing (CMC)
1983/03/14 SUPPL-2(补充) Approval Manufacturing (CMC)
1982/10/07 SUPPL-1(补充) Approval Labeling
1981/10/23 SUPPL-19(补充) Approval Manufacturing (CMC)
1980/08/18 SUPPL-18(补充) Approval Labeling
1980/01/18 SUPPL-17(补充) Approval Manufacturing (CMC)
1979/08/31 SUPPL-16(补充) Approval Labeling
1978/12/08 SUPPL-15(补充) Approval Manufacturing (CMC)
1976/05/17 SUPPL-14(补充) Approval Manufacturing (CMC)
1975/09/11 SUPPL-13(补充) Approval Manufacturing (CMC)
1973/12/14 SUPPL-12(补充) Approval Manufacturing (CMC)
1972/06/05 SUPPL-9(补充) Approval Manufacturing (CMC)
1971/02/11 SUPPL-8(补充) Approval Labeling
1970/12/22 SUPPL-6(补充) Approval Manufacturing (CMC)
1970/12/19 SUPPL-7(补充) Approval Labeling
1970/08/17 SUPPL-5(补充) Approval Manufacturing (CMC)
1970/06/04 ORIG-1(原始申请) Approval UNKNOWN
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:COLISTIMETHATE SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 150MG BASE/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
050108 002 NDA COLY-MYCIN M COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL Prescription Yes Yes AP Approved Prior to Jan 1, 1982 ENDO OPERATIONS
064216 001 ANDA COLISTIMETHATE SODIUM COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL Prescription No No AP 1999/02/26 ADRASTEA PHARMA
065177 001 ANDA COLISTIMETHATE SODIUM COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL Prescription No No AP 2004/03/19 NEXUS
065364 001 ANDA COLISTIMETHATE SODIUM COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL Prescription No No AP 2008/04/17 FRESENIUS KABI USA
202359 001 ANDA COLISTIMETHATE SODIUM COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL Prescription No No AP 2012/09/28 AVET LIFESCIENCES
201365 001 ANDA COLISTIMETHATE SODIUM COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL Prescription No No AP 2014/02/19 SAGENT PHARMS INC
205356 001 ANDA COLISTIMETHATE SODIUM COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL Prescription No No AP 2015/05/29 XELLIA PHARMS APS
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