药品注册申请号：013684
申请类型：NDA (新药申请)
申请人：BAXTER HLTHCARE
申请人全名：BAXTER HEALTHCARE CORP
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 OSMITROL 5% IN WATER MANNITOL INJECTABLE;INJECTION 5GM/100ML No No AP 1964/06/08 Approved Prior to Jan 1, 1982 Prescription
002 OSMITROL 10% IN WATER MANNITOL INJECTABLE;INJECTION 10GM/100ML No No AP Approved Prior to Jan 1, 1982 Prescription
003 OSMITROL 20% IN WATER MANNITOL INJECTABLE;INJECTION 20GM/100ML No No AP Approved Prior to Jan 1, 1982 Prescription
004 OSMITROL 15% IN WATER MANNITOL INJECTABLE;INJECTION 15GM/100ML No No AP Approved Prior to Jan 1, 1982 Prescription
005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 5GM/100ML No No AP Approved Prior to Jan 1, 1982 Prescription
006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 10GM/100ML No No AP Approved Prior to Jan 1, 1982 Prescription
007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 20GM/100ML No No AP Approved Prior to Jan 1, 1982 Prescription
008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 15GM/100ML No No AP 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
2019/08/05 SUPPL-106（补充） Approval Labeling STANDARD
2018/11/15 SUPPL-104（补充） Approval Efficacy STANDARD
2018/11/15 SUPPL-98（补充） Approval Labeling STANDARD
2015/12/23 SUPPL-101（补充） Approval Manufacturing (CMC) STANDARD
2015/07/15 SUPPL-100（补充） Approval Manufacturing (CMC) STANDARD
2015/04/08 SUPPL-99（补充） Approval Manufacturing (CMC) STANDARD
2013/07/19 SUPPL-97（补充） Approval Manufacturing (CMC) STANDARD
2005/08/26 SUPPL-92（补充） Approval Supplement STANDARD
2005/06/09 SUPPL-91（补充） Approval Labeling STANDARD
2002/01/16 SUPPL-87（补充） Approval Manufacturing (CMC) STANDARD
2001/08/14 SUPPL-86（补充） Approval Manufacturing (CMC) STANDARD
1999/11/24 SUPPL-85（补充） Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL-84（补充） Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL-82（补充） Approval Manufacturing (CMC) STANDARD
1994/06/01 SUPPL-81（补充） Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL-83（补充） Approval Manufacturing (CMC) STANDARD
1991/04/29 SUPPL-79（补充） Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL-78（补充） Approval Manufacturing (CMC) STANDARD
1991/02/15 SUPPL-77（补充） Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL-76（补充） Approval Manufacturing (CMC) STANDARD
1987/07/25 SUPPL-75（补充） Approval Manufacturing (CMC) STANDARD
1987/05/28 SUPPL-74（补充） Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL-65（补充） Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL-64（补充） Approval Manufacturing (CMC) STANDARD
1985/06/13 SUPPL-70（补充） Approval Manufacturing (CMC) STANDARD
1985/04/15 SUPPL-71（补充） Approval Manufacturing (CMC) STANDARD
1985/01/24 SUPPL-62（补充） Approval Manufacturing (CMC) STANDARD
1984/09/22 SUPPL-69（补充） Approval Manufacturing (CMC) STANDARD
1984/03/16 SUPPL-63（补充） Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL-68（补充） Approval Manufacturing (CMC) STANDARD
1983/07/11 SUPPL-67（补充） Approval Labeling
1982/11/22 SUPPL-55（补充） Approval Labeling
1982/11/22 SUPPL-51（补充） Approval Labeling
1982/11/22 SUPPL-50（补充） Approval Manufacturing (CMC) STANDARD
1982/06/03 SUPPL-56（补充） Approval Manufacturing (CMC) STANDARD
1982/04/16 SUPPL-54（补充） Approval Manufacturing (CMC) STANDARD
1982/04/08 SUPPL-60（补充） Approval Labeling
1982/02/16 SUPPL-59（补充） Approval Manufacturing (CMC) STANDARD
1981/11/20 SUPPL-58（补充） Approval Manufacturing (CMC) STANDARD
1981/09/08 SUPPL-46（补充） Approval Labeling
1981/09/08 SUPPL-45（补充） Approval Manufacturing (CMC) STANDARD
1981/09/08 SUPPL-44（补充） Approval Labeling
1981/09/08 SUPPL-43（补充） Approval Manufacturing (CMC) STANDARD
1981/08/26 SUPPL-53（补充） Approval Labeling
1981/06/29 SUPPL-49（补充） Approval Manufacturing (CMC) STANDARD
1981/04/16 SUPPL-42（补充） Approval Manufacturing (CMC) STANDARD
1981/01/21 SUPPL-48（补充） Approval Manufacturing (CMC) STANDARD
1980/08/07 SUPPL-39（补充） Approval Manufacturing (CMC) STANDARD
1980/07/31 SUPPL-47（补充） Approval Manufacturing (CMC) STANDARD
1980/06/28 SUPPL-37（补充） Approval Manufacturing (CMC) STANDARD
1980/06/18 SUPPL-41（补充） Approval Manufacturing (CMC) STANDARD
1980/05/30 SUPPL-40（补充） Approval Manufacturing (CMC) STANDARD
1980/02/25 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
1979/08/07 SUPPL-25（补充） Approval Labeling
1979/08/02 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
1979/04/25 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1978/10/20 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
1978/08/07 SUPPL-33（补充） Approval Manufacturing (CMC) STANDARD
1978/06/20 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
1978/03/24 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
1978/03/22 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
1978/02/28 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
1977/12/14 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
1977/08/30 SUPPL-23（补充） Approval Labeling
1977/04/08 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1977/02/07 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1976/10/07 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1976/07/13 SUPPL-20（补充） Approval Labeling
1976/07/01 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
1976/06/17 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
1976/01/05 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1975/09/25 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1975/09/17 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1975/07/29 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1975/07/10 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1975/06/16 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1974/11/11 SUPPL-8（补充） Approval Supplement STANDARD
1964/06/08 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer 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
无
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
无
与本品治疗等效的药品
活性成分:MANNITOL 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML 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
013684 001 NDA OSMITROL 5% IN WATER MANNITOL INJECTABLE;INJECTION 5GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
013684 005 NDA OSMITROL 5% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 5GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
020006 001 NDA MANNITOL 5% IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 5GM/100ML Prescription No No AP 1993/07/26 B BRAUN
活性成分:MANNITOL 剂型/给药途径:INJECTABLE;INJECTION 规格:10GM/100ML 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
013684 002 NDA OSMITROL 10% IN WATER MANNITOL INJECTABLE;INJECTION 10GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
013684 006 NDA OSMITROL 10% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 10GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
020006 002 NDA MANNITOL 10% IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 10GM/100ML Prescription No No AP 1993/07/26 B BRAUN
活性成分:MANNITOL 剂型/给药途径:INJECTABLE;INJECTION 规格:20GM/100ML 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
013684 003 NDA OSMITROL 20% IN WATER MANNITOL INJECTABLE;INJECTION 20GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
013684 007 NDA OSMITROL 20% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 20GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
019603 004 NDA MANNITOL 20% IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 20GM/100ML Prescription No No AP 1990/01/08 ICU MEDICAL INC
020006 004 NDA MANNITOL 20% IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 20GM/100ML Prescription No No AP 1993/07/26 B BRAUN
活性成分:MANNITOL 剂型/给药途径:INJECTABLE;INJECTION 规格:15GM/100ML 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
013684 004 NDA OSMITROL 15% IN WATER MANNITOL INJECTABLE;INJECTION 15GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
013684 008 NDA OSMITROL 15% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 15GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
020006 003 NDA MANNITOL 15% IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 15GM/100ML Prescription No No AP 1993/07/26 B BRAUN
活性成分:MANNITOL 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML 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
013684 001 NDA OSMITROL 5% IN WATER MANNITOL INJECTABLE;INJECTION 5GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
013684 005 NDA OSMITROL 5% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 5GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
020006 001 NDA MANNITOL 5% IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 5GM/100ML Prescription No No AP 1993/07/26 B BRAUN
活性成分:MANNITOL 剂型/给药途径:INJECTABLE;INJECTION 规格:10GM/100ML 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
013684 002 NDA OSMITROL 10% IN WATER MANNITOL INJECTABLE;INJECTION 10GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
013684 006 NDA OSMITROL 10% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 10GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
020006 002 NDA MANNITOL 10% IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 10GM/100ML Prescription No No AP 1993/07/26 B BRAUN
活性成分:MANNITOL 剂型/给药途径:INJECTABLE;INJECTION 规格:20GM/100ML 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
013684 003 NDA OSMITROL 20% IN WATER MANNITOL INJECTABLE;INJECTION 20GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
013684 007 NDA OSMITROL 20% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 20GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
019603 004 NDA MANNITOL 20% IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 20GM/100ML Prescription No No AP 1990/01/08 ICU MEDICAL INC
020006 004 NDA MANNITOL 20% IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 20GM/100ML Prescription No No AP 1993/07/26 B BRAUN
活性成分:MANNITOL 剂型/给药途径:INJECTABLE;INJECTION 规格:15GM/100ML 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
013684 004 NDA OSMITROL 15% IN WATER MANNITOL INJECTABLE;INJECTION 15GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
013684 008 NDA OSMITROL 15% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 15GM/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
020006 003 NDA MANNITOL 15% IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 15GM/100ML Prescription No No AP 1993/07/26 B BRAUN
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