药品注册申请号:018316
申请类型:NDA (新药申请)
申请人:ICU MEDICAL INC
申请人全名:ICU MEDICAL 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 SORBITOL-MANNITOL IN PLASTIC CONTAINER MANNITOL; SORBITOL SOLUTION;IRRIGATION 540MG/100ML;2.7GM/100ML Yes Yes None 1980/02/22 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
1999/01/05 SUPPL-46(补充) Approval Labeling
1997/08/21 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1997/06/11 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
1997/03/28 SUPPL-45(补充) Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1995/08/14 SUPPL-43(补充) Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
1989/09/13 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1987/07/30 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1986/08/29 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1986/02/22 SUPPL-25(补充) Approval Labeling
1986/02/22 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1986/02/21 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1985/10/29 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1985/09/26 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1985/06/17 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1984/09/22 SUPPL-13(补充) Approval Labeling
1984/09/22 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1984/09/21 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1984/03/21 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1984/02/17 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1982/06/14 SUPPL-5(补充) Approval Labeling
1982/06/09 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1982/02/01 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1982/01/08 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1981/09/16 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1980/09/15 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1980/06/16 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1980/06/12 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1980/06/03 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1980/02/22 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)
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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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