药品注册申请号:040682
申请类型:ANDA (仿制药申请)
申请人:ORIT LABS LLC
申请人全名:ORIT LABORATORIES 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 BENZONATATE BENZONATATE CAPSULE;ORAL 100MG No No AA 2007/07/30 2007/07/30 Prescription
002 BENZONATATE BENZONATATE CAPSULE;ORAL 200MG No No AA 2007/07/30 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2011/03/01 SUPPL 4 Approval Labeling
2010/04/06 SUPPL 3 Approval Manufacturing (CMC)
2007/07/30 ORIG 1 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:BENZONATATE 剂型/给药途径:CAPSULE;ORAL 规格:100MG 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
011210 001 NDA TESSALON BENZONATATE CAPSULE;ORAL 100MG Prescription Yes No AA Approved Prior to Jan 1, 1982 PFIZER
081297 001 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 100MG Prescription No No AA 1993/01/29 BIONPHARMA INC
040627 001 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 100MG Prescription No Yes AA 2007/03/30 THEPHARMANETWORK LLC
040597 001 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 100MG Prescription No No AA 2007/06/08 ZYDUS PHARMS USA
040682 001 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 100MG Prescription No No AA 2007/07/30 ORIT LABS LLC
040851 001 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 100MG Prescription No No AA 2009/11/09 MIKART
091310 001 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 100MG Prescription No No AA 2015/01/16 APOTEX INC
091133 001 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 100MG Prescription No No AA 2015/07/30 STRIDES PHARMA
202765 002 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 100MG Prescription No No AA 2017/08/25 CSPC OUYI
210562 001 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 100MG Prescription No No AA 2018/11/09 QINGDAO BAHEAL PHARM
206948 001 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 100MG Prescription No No AA 2018/12/19 PURACAP PHARM LLC
211518 001 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 100MG Prescription No No AA 2019/02/22 ASCENT PHARMS INC
活性成分:BENZONATATE 剂型/给药途径:CAPSULE;ORAL 规格:200MG 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
040597 002 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 200MG Prescription No No AA 2007/06/08 ZYDUS PHARMS USA
040749 001 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 200MG Prescription No Yes AA 2007/07/25 THEPHARMANETWORK LLC
040682 002 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 200MG Prescription No No AA 2007/07/30 ORIT LABS LLC
081297 002 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 200MG Prescription No No AA 2007/10/30 BIONPHARMA INC
040851 003 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 200MG Prescription No No AA 2009/11/09 MIKART
091310 002 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 200MG Prescription No No AA 2015/01/16 APOTEX INC
091133 002 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 200MG Prescription No No AA 2015/07/30 STRIDES PHARMA
202765 001 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 200MG Prescription No No AA 2015/07/31 CSPC OUYI
210562 003 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 200MG Prescription No No AA 2018/11/09 QINGDAO BAHEAL PHARM
206948 002 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 200MG Prescription No No AA 2018/12/19 PURACAP PHARM LLC
211518 003 ANDA BENZONATATE BENZONATATE CAPSULE;ORAL 200MG Prescription No No AA 2019/02/22 ASCENT PHARMS INC
更多信息
药品NDC数据与药品包装、标签说明书
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