药品注册申请号:210959
申请类型:ANDA (仿制药申请)
申请人:LAURUS
申请人全名:LAURUS LABS LTD
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 HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG No No AB 2019/01/15 2019/01/15 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
2024/02/01 SUPPL-15(补充) Approval Labeling STANDARD
2024/01/08 SUPPL-14(补充) Approval Labeling STANDARD
2023/07/12 SUPPL-12(补充) Approval Labeling STANDARD
2023/07/12 SUPPL-10(补充) Approval Labeling STANDARD
2023/03/06 SUPPL-13(补充) Approval Manufacturing (CMC) UNKNOWN
2020/04/01 SUPPL-5(补充) Approval Labeling STANDARD
2020/04/01 SUPPL-1(补充) Approval Labeling STANDARD
2019/01/15 ORIG-1(原始申请) Approval 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:HYDROXYCHLOROQUINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:200MG 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
009768 001 NDA PLAQUENIL HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 CONCORDIA
040081 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 1994/09/30 TEVA PHARMS
040104 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 1995/11/30 SANDOZ
040133 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Discontinued No No AB 1995/11/30 WATSON LABS
040150 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 1996/01/27 CREEKWOOD PHARMS
040274 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 1998/05/29 AUROBINDO PHARMA USA
040766 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 2007/06/14 IPCA LABS LTD
040657 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 2007/09/21 ZYDUS PHARMS USA INC
210441 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 2018/05/01 APPCO
201691 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 2018/05/08 ALKALOIDA ZRT
210577 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 2018/05/15 AMNEAL PHARMS CO
210543 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 2018/07/06 CHARTWELL RX
210959 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 2019/01/15 LAURUS
213342 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 2020/04/07 ACCORD HLTHCARE
212902 001 ANDA HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET;ORAL 200MG Prescription No No AB 2020/05/14 SENORES PHARMS
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