药品注册申请号：218688
申请类型：ANDA (仿制药申请)
申请人：VILIN BIO MED
申请人全名：VILIN BIO MED 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 BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL No No AP 2025/06/02 2025/06/02 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/06/02 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
无
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
无
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
无
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
213823 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Discontinued No No AP 2022/05/02 BAXTER HLTHCARE CORP
212825 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/05/02 EUGIA PHARMA
212958 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/07/26 MEITHEAL
215011 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2022/07/26 JIANGSU HANSOH PHARM
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 RELIANCE LIFE SCI
205160 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Discontinued No No AP 2022/10/31 PHARMOBEDIENT
216912 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Discontinued No No AP 2023/09/26 SCINOPHARM TAIWAN
212204 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2024/05/03 HETERO LABS LTD VI
218688 001 ANDA BORTEZOMIB BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL Prescription No No AP 2025/06/02 VILIN BIO MED
更多信息
药品NDC数据与药品包装、标签说明书
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