药品注册申请号:050095
申请类型:NDA (新药申请)
申请人:EPIC PHARMA LLC
申请人全名:EPIC PHARMA 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 CAPASTAT SULFATE CAPREOMYCIN SULFATE INJECTABLE;INJECTION EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1971/06/02 Approved Prior to Jan 1, 1982 Discontinued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
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
2023/01/17 SUPPL-78(补充) Approval Labeling STANDARD
2019/10/01 SUPPL-74(补充) Approval Labeling STANDARD
2019/01/16 SUPPL-72(补充) Approval Labeling STANDARD
2008/07/24 SUPPL-62(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.
2003/06/11 SUPPL-44(补充) Approval Labeling STANDARD
2001/10/05 SUPPL-43(补充) Approval Manufacturing (CMC)
1996/10/03 SUPPL-41(补充) Approval Labeling STANDARD
1995/12/21 SUPPL-42(补充) Approval Manufacturing (CMC)
1988/09/12 SUPPL-9(补充) Approval Labeling
1987/08/12 SUPPL-38(补充) Approval Labeling
1987/07/08 SUPPL-37(补充) Approval Labeling
1987/07/08 SUPPL-7(补充) Approval Labeling
1987/05/26 SUPPL-36(补充) Approval Labeling
1987/05/26 SUPPL-8(补充) Approval Labeling
1987/05/26 SUPPL-6(补充) Approval Labeling
1987/03/06 SUPPL-35(补充) Approval Manufacturing (CMC)
1986/12/09 SUPPL-5(补充) Approval Labeling
1985/01/18 SUPPL-34(补充) Approval Manufacturing (CMC)
1985/01/18 SUPPL-4(补充) Approval Labeling
1983/09/26 SUPPL-33(补充) Approval Manufacturing (CMC)
1983/09/26 SUPPL-3(补充) Approval Labeling
1983/08/23 SUPPL-32(补充) Approval Labeling
1983/08/23 SUPPL-2(补充) Approval Labeling
1983/08/05 SUPPL-31(补充) Approval Labeling
1983/08/05 SUPPL-1(补充) Approval Labeling
1982/08/31 SUPPL-30(补充) Approval Manufacturing (CMC)
1982/04/12 SUPPL-29(补充) Approval Manufacturing (CMC)
1981/05/29 SUPPL-28(补充) Approval Manufacturing (CMC)
1981/03/11 SUPPL-27(补充) Approval Labeling
1981/03/04 SUPPL-26(补充) Approval Manufacturing (CMC)
1981/02/11 SUPPL-25(补充) Approval Manufacturing (CMC)
1980/06/03 SUPPL-24(补充) Approval Labeling
1980/01/25 SUPPL-23(补充) Approval Manufacturing (CMC)
1978/11/03 SUPPL-22(补充) Approval Manufacturing (CMC)
1977/09/21 SUPPL-21(补充) Approval Manufacturing (CMC)
1977/09/12 SUPPL-20(补充) Approval Labeling
1976/12/03 SUPPL-19(补充) Approval Labeling
1976/09/14 SUPPL-18(补充) Approval Manufacturing (CMC)
1975/10/28 SUPPL-17(补充) Approval Labeling
1975/09/23 SUPPL-16(补充) Approval Manufacturing (CMC)
1974/09/20 SUPPL-15(补充) Approval Manufacturing (CMC)
1973/08/28 SUPPL-14(补充) Approval Manufacturing (CMC)
1973/07/18 SUPPL-13(补充) Approval Labeling
1972/08/29 SUPPL-12(补充) Approval Manufacturing (CMC)
1972/02/25 SUPPL-11(补充) Approval Labeling
1971/12/20 SUPPL-10(补充) Approval Manufacturing (CMC)
1971/06/02 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)
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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
与本品治疗等效的药品
本品无治疗等效药品
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