药品注册申请号:016093
申请类型:NDA (新药申请)
申请人:BAUSCH
申请人全名:BAUSCH HEALTH AMERICAS 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 EDECRIN ETHACRYNATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL Yes Yes AP 1967/01/10 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
2005/07/20 SUPPL-45(补充) Approval Manufacturing (CMC) STANDARD
2005/02/09 SUPPL-44(补充) Approval Labeling STANDARD
2004/02/03 SUPPL-43(补充) Approval Labeling STANDARD
2002/06/10 SUPPL-42(补充) Approval Manufacturing (CMC) STANDARD
2001/07/19 SUPPL-41(补充) Approval Manufacturing (CMC) STANDARD
2001/06/18 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
2001/02/14 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
1999/10/19 SUPPL-38(补充) Approval Labeling STANDARD
1999/09/03 SUPPL-37(补充) Approval Manufacturing (CMC) STANDARD
1997/11/03 SUPPL-36(补充) Approval Labeling STANDARD
1996/10/08 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1995/11/30 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1995/03/24 SUPPL-34(补充) Approval Labeling STANDARD
1991/08/07 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1989/05/30 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1986/12/08 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1986/03/21 SUPPL-29(补充) Approval Labeling
1986/01/13 SUPPL-28(补充) Approval Labeling
1985/08/27 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1985/05/13 SUPPL-20(补充) Approval Labeling
1984/10/11 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1984/08/28 SUPPL-25(补充) Approval Labeling
1983/09/20 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1983/05/19 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1981/11/03 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1981/08/28 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1981/07/14 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1981/02/19 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1981/01/16 SUPPL-18(补充) Approval Labeling
1980/01/25 SUPPL-16(补充) Approval Labeling
1979/06/21 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1978/08/28 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1978/08/28 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1978/03/10 SUPPL-13(补充) Approval Labeling
1976/01/29 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1967/01/10 ORIG-1(原始申请) Approval Type 2 - New Active Ingredient 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:ETHACRYNATE SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 50MG 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
016093 001 NDA EDECRIN ETHACRYNATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAUSCH
205473 001 ANDA ETHACRYNATE SODIUM ETHACRYNATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL Prescription No No AP 2015/07/29 ENDO OPERATIONS
204634 001 ANDA ETHACRYNATE SODIUM ETHACRYNATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL Prescription No No AP 2016/08/23 MYLAN INSTITUTIONAL
207758 001 ANDA ETHACRYNATE SODIUM ETHACRYNATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL Prescription No No AP 2017/11/17 ZYDUS PHARMS
208663 001 ANDA ETHACRYNATE SODIUM ETHACRYNATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL Prescription No No AP 2020/06/09 STERIMAX
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