药品注册申请号:017441
申请类型:NDA (新药申请)
申请人:ALLERGAN
申请人全名:ALLERGAN SALES 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 INFED FERRIC OXYHYDROXIDE INJECTABLE;INJECTION EQ 100MG IRON/2ML (EQ 50MG IRON/ML) Yes Yes BP 1974/04/29 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
2021/09/14 SUPPL-180(补充) Approval Labeling STANDARD
2021/04/20 SUPPL-179(补充) Approval Labeling STANDARD
2020/09/11 SUPPL-178(补充) Approval Labeling STANDARD
2009/08/12 SUPPL-171(补充) Approval Labeling STANDARD
2002/11/26 SUPPL-164(补充) Approval Manufacturing (CMC) PRIORITY
2001/11/20 SUPPL-162(补充) Approval Manufacturing (CMC) PRIORITY
2001/07/24 SUPPL-160(补充) Approval Manufacturing (CMC) PRIORITY
2001/07/23 SUPPL-159(补充) Approval Manufacturing (CMC) PRIORITY
2001/04/18 SUPPL-161(补充) Approval Labeling STANDARD
1999/09/13 SUPPL-158(补充) Approval Manufacturing (CMC) PRIORITY
1999/04/15 SUPPL-157(补充) Approval Manufacturing (CMC) PRIORITY
1999/01/13 SUPPL-155(补充) Approval Manufacturing (CMC) PRIORITY
1999/01/13 SUPPL-154(补充) Approval Manufacturing (CMC) PRIORITY
1998/05/22 SUPPL-153(补充) Approval Manufacturing (CMC) PRIORITY
1997/04/04 SUPPL-151(补充) Approval Labeling STANDARD
1997/04/04 SUPPL-150(补充) Approval Labeling STANDARD
1997/02/21 SUPPL-152(补充) Approval Manufacturing (CMC) PRIORITY
1995/08/11 SUPPL-149(补充) Approval Manufacturing (CMC) PRIORITY
1994/04/13 SUPPL-148(补充) Approval Labeling STANDARD
1994/04/12 SUPPL-146(补充) Approval Manufacturing (CMC) PRIORITY
1992/04/22 SUPPL-145(补充) Approval Manufacturing (CMC) PRIORITY
1991/08/05 SUPPL-144(补充) Approval Labeling
1991/07/12 SUPPL-143(补充) Approval Labeling
1991/07/12 SUPPL-142(补充) Approval Manufacturing (CMC) PRIORITY
1991/07/12 SUPPL-141(补充) Approval Manufacturing (CMC) PRIORITY
1988/01/12 SUPPL-139(补充) Approval Labeling
1986/04/07 SUPPL-138(补充) Approval Manufacturing (CMC) PRIORITY
1985/05/13 SUPPL-137(补充) Approval Labeling
1981/06/17 SUPPL-135(补充) Approval Labeling
1981/06/15 SUPPL-134(补充) Approval Labeling
1981/06/15 SUPPL-133(补充) Approval Labeling
1981/06/15 SUPPL-132(补充) Approval Labeling
1981/03/05 SUPPL-130(补充) Approval Labeling
1981/03/05 SUPPL-129(补充) Approval Labeling
1981/02/18 SUPPL-131(补充) Approval Labeling
1981/02/03 SUPPL-128(补充) Approval Labeling
1981/01/16 SUPPL-127(补充) Approval Labeling
1980/08/20 SUPPL-126(补充) Approval Labeling
1980/08/20 SUPPL-125(补充) Approval Labeling
1980/07/07 SUPPL-121(补充) Approval Labeling
1980/04/01 SUPPL-120(补充) Approval Labeling
1980/01/21 SUPPL-119(补充) Approval Labeling
1980/01/21 SUPPL-118(补充) Approval Labeling
1980/01/21 SUPPL-117(补充) Approval Labeling
1980/01/21 SUPPL-116(补充) Approval Labeling
1980/01/21 SUPPL-115(补充) Approval Labeling
1980/01/21 SUPPL-114(补充) Approval Labeling
1980/01/21 SUPPL-113(补充) Approval Labeling
1979/08/13 SUPPL-111(补充) Approval Labeling
1979/08/13 SUPPL-110(补充) Approval Labeling
1979/08/13 SUPPL-109(补充) Approval Labeling
1979/08/13 SUPPL-108(补充) Approval Labeling
1979/08/13 SUPPL-107(补充) Approval Labeling
1979/08/13 SUPPL-106(补充) Approval Labeling
1979/08/13 SUPPL-105(补充) Approval Labeling
1978/08/07 SUPPL-104(补充) Approval Labeling
1978/07/31 SUPPL-103(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-102(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-101(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-100(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-99(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-98(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-97(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-96(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-95(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-94(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-93(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-92(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-91(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-90(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-89(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-88(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-87(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-86(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-85(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-84(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-83(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-82(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-81(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-80(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-79(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-78(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-77(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-76(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-75(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-74(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-73(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-72(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-71(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-70(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-69(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-68(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-67(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-66(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-65(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-64(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-63(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-62(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-61(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/31 SUPPL-60(补充) Approval Labeling
1978/07/31 SUPPL-59(补充) Approval Labeling
1978/07/31 SUPPL-58(补充) Approval Labeling
1978/07/31 SUPPL-57(补充) Approval Labeling
1978/07/31 SUPPL-56(补充) Approval Labeling
1978/07/31 SUPPL-27(补充) Approval Labeling
1976/10/04 SUPPL-54(补充) Approval Labeling
1976/10/04 SUPPL-53(补充) Approval Labeling
1976/10/04 SUPPL-52(补充) Approval Labeling
1976/10/04 SUPPL-51(补充) Approval Labeling
1976/10/04 SUPPL-50(补充) Approval Labeling
1976/10/04 SUPPL-48(补充) Approval Labeling
1976/10/04 SUPPL-47(补充) Approval Labeling
1976/10/04 SUPPL-46(补充) Approval Labeling
1976/10/04 SUPPL-43(补充) Approval Labeling
1976/10/04 SUPPL-42(补充) Approval Labeling
1976/10/04 SUPPL-41(补充) Approval Labeling
1976/10/04 SUPPL-40(补充) Approval Labeling
1976/10/04 SUPPL-39(补充) Approval Labeling
1976/10/04 SUPPL-38(补充) Approval Labeling
1976/10/04 SUPPL-37(补充) Approval Labeling
1976/10/04 SUPPL-36(补充) Approval Labeling
1976/10/04 SUPPL-35(补充) Approval Labeling
1976/10/04 SUPPL-34(补充) Approval Labeling
1976/10/04 SUPPL-33(补充) Approval Labeling
1976/10/04 SUPPL-32(补充) Approval Labeling
1976/10/04 SUPPL-31(补充) Approval Labeling
1976/10/04 SUPPL-30(补充) Approval Labeling
1976/10/04 SUPPL-29(补充) Approval Labeling
1976/10/04 SUPPL-28(补充) Approval Labeling
1976/10/04 SUPPL-26(补充) Approval Labeling
1976/10/04 SUPPL-25(补充) Approval Labeling
1976/10/04 SUPPL-23(补充) Approval Labeling
1976/10/04 SUPPL-22(补充) Approval Labeling
1976/10/04 SUPPL-21(补充) Approval Labeling
1976/10/04 SUPPL-20(补充) Approval Labeling
1976/10/04 SUPPL-19(补充) Approval Labeling
1976/10/04 SUPPL-18(补充) Approval Labeling
1976/10/04 SUPPL-17(补充) Approval Labeling
1976/10/04 SUPPL-16(补充) Approval Labeling
1976/10/04 SUPPL-15(补充) Approval Labeling
1976/01/22 SUPPL-45(补充) Approval Manufacturing (CMC) PRIORITY
1975/03/26 SUPPL-13(补充) Approval Labeling
1975/03/26 SUPPL-12(补充) Approval Labeling
1975/03/26 SUPPL-11(补充) Approval Labeling
1974/04/29 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer 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
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:FERRIC OXYHYDROXIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 100MG IRON/2ML (EQ 50MG IRON/ML) 治疗等效代码:BP
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
017441 001 NDA INFED FERRIC OXYHYDROXIDE INJECTABLE;INJECTION EQ 100MG IRON/2ML (EQ 50MG IRON/ML) Prescription Yes Yes BP Approved Prior to Jan 1, 1982 ALLERGAN
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