药品注册申请号:091264
申请类型:ANDA (仿制药申请)
申请人:HETERO LABS LTD III
申请人全名:HETERO LABS LTD UNIT III
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 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG No No AB 2012/06/29 2012/06/29 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
2019/06/28 SUPPL-10(补充) Approval Labeling STANDARD
2019/06/28 SUPPL-8(补充) Approval Labeling STANDARD
2017/09/18 SUPPL-5(补充) Approval Labeling STANDARD
2015/11/24 SUPPL-3(补充) Approval Labeling STANDARD
2013/01/30 SUPPL-2(补充) Approval Labeling STANDARD
2012/11/29 SUPPL-1(补充) Approval Labeling STANDARD
2012/06/29 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:LEVOCETIRIZINE DIHYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:5MG 治疗等效代码:AB
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
090229 001 ANDA LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2010/11/26 SYNTHON PHARMS
090385 001 ANDA LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG Prescription No Yes AB 2011/02/24 GLENMARK PHARMS LTD
090392 001 ANDA LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/02/24 DR REDDYS LABS LTD
090199 001 ANDA LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/08/22 TEVA PHARMS
091264 001 ANDA LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2012/06/29 HETERO LABS LTD III
090362 001 ANDA LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2013/01/31 SUN PHARM
202046 001 ANDA LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2013/09/17 MICRO LABS LTD INDIA
203646 001 ANDA LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2014/09/09 SCIEGEN PHARMS INC
205564 001 ANDA LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2016/01/11 MACLEODS PHARMS LTD
204626 001 ANDA LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2024/05/06 IPCA LABS LTD
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