药品注册申请号：018983
申请类型：NDA (新药申请)
申请人：NORVIUM BIOSCIENCE
申请人全名：NORVIUM BIOSCIENCE 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
004 COLYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1984/10/26 1984/10/26 Discontinued
005 COLYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1984/10/26 Discontinued
006 COLYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1984/10/26 Discontinued
007 COLYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1987/06/12 Discontinued
008 COLYTE-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1991/11/14 Discontinued
009 COLYTE-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1991/11/14 Discontinued
010 COLYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1989/01/31 Discontinued
012 COLYTE WITH FLAVOR PACKS POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT No No AA 1998/10/08 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
2021/05/14 SUPPL-51（补充） Approval Labeling STANDARD
2013/08/19 SUPPL-47（补充） Approval Labeling STANDARD
2013/04/24 SUPPL-45（补充） Approval Manufacturing (CMC) STANDARD
2003/10/23 SUPPL-37（补充） Approval Labeling STANDARD
2002/11/12 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
2002/09/16 SUPPL-35（补充） Approval Labeling STANDARD
2002/05/16 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
2000/10/16 SUPPL-31（补充） Approval Labeling STANDARD
2000/10/16 SUPPL-30（补充） Approval Labeling STANDARD
2000/10/12 SUPPL-33（补充） Approval Manufacturing (CMC) STANDARD
2000/07/20 SUPPL-32（补充） Approval Manufacturing (CMC) STANDARD
1999/11/30 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
1999/07/21 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
1998/10/08 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
1998/04/17 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
1997/12/09 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
1997/01/21 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1996/09/06 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1996/01/24 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1994/10/13 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
1994/06/06 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1994/04/25 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1994/04/25 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
1994/04/04 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
1994/02/24 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
1993/03/05 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1991/11/14 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1990/06/26 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1989/01/31 SUPPL-8（补充） Approval Labeling
1989/01/31 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1987/06/12 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1986/08/19 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
1986/08/19 SUPPL-1（补充） Approval Labeling
1986/03/27 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1984/10/26 ORIG-1（原始申请） Approval Type 4 - New Combination 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:POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 剂型/给药途径:FOR SOLUTION;ORAL 规格:240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT 治疗等效代码:AA
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
018983 012 NDA COLYTE WITH FLAVOR PACKS POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Discontinued No No AA 1998/10/08 NORVIUM BIOSCIENCE
090186 001 ANDA PEG 3350 AND ELECTROLYTES POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Prescription No No AA 2009/06/01 NOVEL LABS INC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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