药品注册申请号:205533
申请类型:ANDA (仿制药申请)
申请人:APOTEX
申请人全名:APOTEX 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 BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL No No AP 2022/05/02 2022/05/02 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
2022/05/02 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:BORTEZOMIB 剂型/给药途径:INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 规格:3.5MG/VIAL 治疗等效代码:AP
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
021602 001 NDA VELCADE BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription Yes Yes AP 2003/05/13 TAKEDA PHARMS USA
205533 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/05/02 APOTEX
205857 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Discontinued No No AP 2022/05/02 TEVA PHARMS USA
208392 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/05/02 PHARMASCIENCE INC
209659 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/05/02 FRESENIUS KABI USA
210204 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/05/02 ZYDUS PHARMS
210824 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/05/02 QILU PHARM HAINAN
212825 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/05/02 EUGIA PHARMA
213823 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/05/02 BAXTER HLTHCARE CORP
215011 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/07/26 JIANGSU HANSOH PHARM
212958 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/07/26 MEITHEAL
208460 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/07/26 HOSPIRA
209622 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/07/26 MSN
202963 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/07/26 DR REDDYS
203654 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/07/26 SANDOZ
204405 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Discontinued No No AP 2022/07/26 ACCORD HLTHCARE
211898 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/10/11 WAVERLEY PHARMA INC
205160 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Discontinued No No AP 2022/10/31 MYLAN LABS LTD
216912 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Discontinued No No AP 2023/09/26 SCINOPHARM TAIWAN
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