药品注册申请号:019797
申请类型:NDA (新药申请)
申请人:BRAINTREE
申请人全名:BRAINTREE LABORATORIES 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 NULYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Yes Yes AA 1991/04/22 1991/04/22 Prescription
002 NULYTELY-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Yes Yes AA 1994/11/18 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
2021/05/14 SUPPL-29(补充) Approval Labeling STANDARD
2013/09/23 SUPPL-22(补充) Approval Labeling STANDARD
2010/01/27 SUPPL-18(补充) Approval Labeling STANDARD
2003/08/07 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
2003/06/30 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
2001/02/23 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
2000/01/28 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1999/12/13 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1999/10/09 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1999/03/25 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1997/12/10 SUPPL-7(补充) Approval Labeling STANDARD
1997/12/10 SUPPL-6(补充) Approval Labeling STANDARD
1997/06/03 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1996/11/04 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1995/11/02 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1994/11/18 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1993/04/29 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1991/04/22 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
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:POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 剂型/给药途径:FOR SOLUTION;ORAL 规格:420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/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
019797 001 NDA NULYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Prescription Yes Yes AA 1991/04/22 BRAINTREE
019797 002 NDA NULYTELY-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Prescription Yes Yes AA 1994/11/18 BRAINTREE
090019 001 ANDA PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Prescription No No AA 2009/05/27 NOVEL LABS INC
079232 001 ANDA LAX-LYTE WITH FLAVOR PACKS POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Discontinued No No AA 2010/02/25 L PERRIGO CO
204559 001 ANDA PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Prescription No No AA 2015/04/13 STRIDES PHARMA
活性成分:POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 剂型/给药途径:FOR SOLUTION;ORAL 规格:420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/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
019797 001 NDA NULYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Prescription Yes Yes AA 1991/04/22 BRAINTREE
019797 002 NDA NULYTELY-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Prescription Yes Yes AA 1994/11/18 BRAINTREE
090019 001 ANDA PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Prescription No No AA 2009/05/27 NOVEL LABS INC
079232 001 ANDA LAX-LYTE WITH FLAVOR PACKS POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Discontinued No No AA 2010/02/25 L PERRIGO CO
204559 001 ANDA PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Prescription No No AA 2015/04/13 STRIDES PHARMA
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