药品注册申请号：012142
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 CYTOXAN CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1959/11/16 Approved Prior to Jan 1, 1982 Discontinued
002 CYTOXAN CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 CYTOXAN (LYOPHILIZED) CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 CYTOXAN (LYOPHILIZED) CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1982/08/30 Discontinued
005 CYTOXAN (LYOPHILIZED) CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1982/08/30 Discontinued
006 LYOPHILIZED CYTOXAN CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1985/12/05 Discontinued
007 LYOPHILIZED CYTOXAN CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1985/12/10 Discontinued
008 CYTOXAN (LYOPHILIZED) CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/01/04 Discontinued
009 CYTOXAN (LYOPHILIZED) CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1985/12/10 Discontinued
010 CYTOXAN (LYOPHILIZED) CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1985/09/24 Discontinued
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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1959/11/16 ORIG-1（原始申请） Approval Type 2 - New Active Ingredient PRIORITY
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2024/09/05 SUPPL-116（补充） Approval Labeling-Package Insert STANDARD
2016/10/31 SUPPL-115（补充） Approval Manufacturing (CMC) STANDARD
2014/07/22 SUPPL-114（补充） Approval Manufacturing (CMC) PRIORITY
2013/05/07 SUPPL-112（补充） Approval Labeling-Package Insert STANDARD
2012/03/31 SUPPL-109（补充） Approval Labeling STANDARD
2003/11/07 SUPPL-107（补充） Approval Manufacturing (CMC)-Formulation PRIORITY
2001/01/30 SUPPL-103（补充） Approval Labeling STANDARD
2000/11/02 SUPPL-104（补充） Approval Manufacturing (CMC) PRIORITY
2000/06/15 SUPPL-101（补充） Approval Labeling STANDARD
1999/05/28 SUPPL-102（补充） Approval Labeling STANDARD
1995/12/20 SUPPL-98（补充） Approval Labeling STANDARD
1990/10/22 SUPPL-93（补充） Approval Manufacturing (CMC)-Control PRIORITY
1989/03/01 SUPPL-92（补充） Approval Manufacturing (CMC)-Control PRIORITY
1988/04/28 SUPPL-79（补充） Approval Manufacturing (CMC)-Control PRIORITY
1988/01/12 SUPPL-91（补充） Approval Manufacturing (CMC)-Control PRIORITY
1988/01/11 SUPPL-90（补充） Approval Labeling
1987/11/20 SUPPL-89（补充） Approval Manufacturing (CMC)-Control PRIORITY
1987/04/29 SUPPL-88（补充） Approval Manufacturing (CMC) PRIORITY
1987/04/29 SUPPL-53（补充） Approval Labeling
1987/04/29 SUPPL-28（补充） Approval Efficacy-New Indication
1986/12/08 SUPPL-87（补充） Approval Labeling
1986/12/08 SUPPL-86（补充） Approval Labeling
1986/07/11 SUPPL-83（补充） Approval Labeling
1986/07/11 SUPPL-82（补充） Approval Labeling
1986/07/11 SUPPL-81（补充） Approval Labeling
1986/05/30 SUPPL-85（补充） Approval Labeling
1986/05/30 SUPPL-84（补充） Approval Labeling
1986/05/30 SUPPL-80（补充） Approval Labeling
1986/02/14 SUPPL-77（补充） Approval Labeling
1985/12/10 SUPPL-70（补充） Approval Labeling
1985/12/05 SUPPL-68（补充） Approval Labeling
1985/09/24 SUPPL-69（补充） Approval Labeling
1985/08/30 SUPPL-76（补充） Approval Labeling
1985/08/30 SUPPL-75（补充） Approval Manufacturing (CMC)-Control PRIORITY
1985/08/06 SUPPL-57（补充） Approval Manufacturing (CMC)-Control PRIORITY
1985/06/18 SUPPL-73（补充） Approval Manufacturing (CMC)-Control PRIORITY
1985/05/06 SUPPL-72（补充） Approval Manufacturing (CMC)-Expiration Date PRIORITY
1985/05/02 SUPPL-74（补充） Approval Manufacturing (CMC)-Expiration Date PRIORITY
1984/12/10 SUPPL-71（补充） Approval Manufacturing (CMC)-Expiration Date PRIORITY
1984/10/17 SUPPL-61（补充） Approval Labeling
1984/08/20 SUPPL-65（补充） Approval Manufacturing (CMC)-Control PRIORITY
1984/07/18 SUPPL-67（补充） Approval Manufacturing (CMC)-Expiration Date PRIORITY
1984/06/15 SUPPL-66（补充） Approval Manufacturing (CMC) PRIORITY
1984/06/14 SUPPL-63（补充） Approval Labeling
1984/06/14 SUPPL-55（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1984/05/24 SUPPL-64（补充） Approval Manufacturing (CMC)-Control PRIORITY
1984/04/05 SUPPL-59（补充） Approval Labeling
1984/01/04 SUPPL-58（补充） Approval Manufacturing (CMC)-Formulation PRIORITY
1983/03/15 SUPPL-56（补充） Approval Labeling
1982/08/30 SUPPL-54（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1982/07/28 SUPPL-52（补充） Approval Manufacturing (CMC)-Control PRIORITY
1981/12/11 SUPPL-47（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1981/11/16 SUPPL-48（补充） Approval Manufacturing (CMC)-Control PRIORITY
1981/10/13 SUPPL-50（补充） Approval Manufacturing (CMC)-Control PRIORITY
1981/03/21 SUPPL-46（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1980/09/27 SUPPL-45（补充） Approval Labeling
1979/12/03 SUPPL-39（补充） Approval Manufacturing (CMC)-Control PRIORITY
1979/08/03 SUPPL-44（补充） Approval Manufacturing (CMC)-Control PRIORITY
1979/06/19 SUPPL-43（补充） Approval Manufacturing (CMC) PRIORITY
1979/02/16 SUPPL-41（补充） Approval Manufacturing (CMC)-Control PRIORITY
1978/12/13 SUPPL-40（补充） Approval Manufacturing (CMC)-Control PRIORITY
1978/08/29 SUPPL-38（补充） Approval Manufacturing (CMC)-Control PRIORITY
1977/04/26 SUPPL-34（补充） Approval Manufacturing (CMC)-Control PRIORITY
1977/04/26 SUPPL-33（补充） Approval Manufacturing (CMC) PRIORITY
1977/04/20 SUPPL-35（补充） Approval Manufacturing (CMC)-Control PRIORITY
1976/11/01 SUPPL-30（补充） Approval Labeling
1976/06/10 SUPPL-29（补充） Approval Manufacturing (CMC) PRIORITY
1976/01/13 SUPPL-25（补充） Approval Manufacturing (CMC)-Control 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
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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
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
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