药品注册申请号:074138
申请类型:ANDA (仿制药申请)
申请人:VISTAPHARM
申请人全名:VISTAPHARM 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 LACTULOSE LACTULOSE SOLUTION;ORAL 10GM/15ML No No AA 1992/09/30 1992/09/30 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
2001/11/28 SUPPL-13(补充) Approval Manufacturing (CMC)
2000/03/27 SUPPL-12(补充) Approval Manufacturing (CMC)
1998/02/24 SUPPL-9(补充) Approval Labeling
1997/12/22 SUPPL-11(补充) Approval Manufacturing (CMC)
1997/12/22 SUPPL-10(补充) Approval Manufacturing (CMC)
1997/01/31 SUPPL-8(补充) Approval Labeling
1997/01/31 SUPPL-7(补充) Approval Manufacturing (CMC)
1996/09/20 SUPPL-6(补充) Approval Labeling
1996/08/07 SUPPL-5(补充) Approval Labeling
1996/08/07 SUPPL-4(补充) Approval Manufacturing (CMC)
1996/08/07 SUPPL-3(补充) Approval Manufacturing (CMC)
1994/02/22 SUPPL-1(补充) Approval Manufacturing (CMC)
1992/09/30 ORIG-1(原始申请) Approval
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:LACTULOSE 剂型/给药途径:SOLUTION;ORAL 规格:10GM/15ML 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
074138 001 ANDA LACTULOSE LACTULOSE SOLUTION;ORAL 10GM/15ML Discontinued No No AA 1992/09/30 VISTAPHARM
074076 001 ANDA LACTULOSE LACTULOSE SOLUTION;ORAL 10GM/15ML Discontinued No No AA 1995/07/03 HIKMA
074623 001 ANDA LACTULOSE LACTULOSE SOLUTION;ORAL 10GM/15ML Prescription No Yes AA 1996/07/30 PHARM ASSOC
074602 001 ANDA LACTULOSE LACTULOSE SOLUTION;ORAL 10GM/15ML Prescription No No AA 1996/11/14 AUROBINDO PHARMA LTD
075993 001 ANDA LACTULOSE LACTULOSE SOLUTION;ORAL 10GM/15ML Prescription No No AA 2001/07/26 LANNETT CO INC
075911 001 ANDA LACTULOSE LACTULOSE SOLUTION;ORAL 10GM/15ML Prescription No No AA 2002/02/21 XTTRIUM LABS INC
090503 001 ANDA LACTULOSE LACTULOSE SOLUTION;ORAL 10GM/15ML Prescription No No AA 2012/01/25 FRESENIUS KABI
207786 001 ANDA LACTULOSE LACTULOSE SOLUTION;ORAL 10GM/15ML Prescription No No AA 2018/06/11 APOZEAL PHARMS
209517 001 ANDA LACTULOSE LACTULOSE SOLUTION;ORAL 10GM/15ML Prescription No No AA 2018/11/23 CHARTWELL RX
更多信息
药品NDC数据与药品包装、标签说明书
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