药品注册申请号：209377
申请类型：NDA (新药申请)
申请人：AM REGENT
申请人全名：AMERICAN REGENT 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 ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 30MG BASE/10ML (EQ 3MG BASE/ML) Yes Yes AP 2019/07/18 2019/07/18 Prescription
002 ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 25MG BASE/5ML (EQ 5MG BASE/ML) Yes Yes AP 2019/07/18 Prescription
003 ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 10MG BASE/10ML (EQ 1MG BASE/ML) Yes Yes AP 2020/04/15 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
>>>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
2019/07/18 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer 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
2020/10/28 SUPPL-3（补充） Approval Labeling-Package Insert 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
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:ZINC SULFATE; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:EQ 30MG BASE/10ML (EQ 3MG BASE/ML); 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
209377 001 NDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 30MG BASE/10ML (EQ 3MG BASE/ML) Prescription Yes Yes AP 2019/07/18 AM REGENT
216249 002 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 30MG BASE/10ML (EQ 3MG BASE/ML) Prescription No No AP 2022/05/03 GLAND
216145 003 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 30MG BASE/10ML (EQ 3MG BASE/ML) Prescription No No AP 2022/12/27 FRESENIUS KABI USA
217074 003 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 30MG BASE/10ML (EQ 3MG BASE/ML) Prescription No No AP 2023/08/22 ZYDUS PHARMS
214597 003 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 30MG BASE/10ML (EQ 3MG BASE/ML) Prescription No No AP 2024/07/05 NIVAGEN PHARMS INC
216135 002 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 30MG BASE/10ML (EQ 3MG BASE/ML) Prescription No No AP 2024/07/17 SOMERSET THERAPS LLC
219585 003 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 30MG BASE/10ML (EQ 3MG BASE/ML) Prescription No No AP 2025/05/01 ASPIRO
217624 003 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 30MG BASE/10ML (EQ 3MG BASE/ML) Prescription No No AP 2025/06/10 RK PHARMA
>>>活性成分:ZINC SULFATE; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:EQ 25MG BASE/5ML (EQ 5MG BASE/ML); 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
209377 002 NDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 25MG BASE/5ML (EQ 5MG BASE/ML) Prescription Yes Yes AP 2019/07/18 AM REGENT
216249 001 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 25MG BASE/5ML (EQ 5MG BASE/ML) Prescription No No AP 2022/05/03 GLAND
216145 002 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 25MG BASE/5ML (EQ 5MG BASE/ML) Prescription No No AP 2022/12/27 FRESENIUS KABI USA
217074 002 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 25MG BASE/5ML (EQ 5MG BASE/ML) Prescription No No AP 2023/08/22 ZYDUS PHARMS
218059 001 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 25MG BASE/5ML (EQ 5MG BASE/ML) Prescription No No AP 2024/06/10 APOTEX
214597 002 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 25MG BASE/5ML (EQ 5MG BASE/ML) Prescription No No AP 2024/07/05 NIVAGEN PHARMS INC
216135 001 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 25MG BASE/5ML (EQ 5MG BASE/ML) Prescription No No AP 2024/07/17 SOMERSET THERAPS LLC
219585 002 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 25MG BASE/5ML (EQ 5MG BASE/ML) Prescription No No AP 2025/05/01 ASPIRO
217624 002 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 25MG BASE/5ML (EQ 5MG BASE/ML) Prescription No No AP 2025/06/10 RK PHARMA
>>>活性成分:ZINC SULFATE; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:EQ 10MG BASE/10ML (EQ 1MG BASE/ML); 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
209377 003 NDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 10MG BASE/10ML (EQ 1MG BASE/ML) Prescription Yes Yes AP 2020/04/15 AM REGENT
216145 001 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 10MG BASE/10ML (EQ 1MG BASE/ML) Prescription No No AP 2022/12/27 FRESENIUS KABI USA
217074 001 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 10MG BASE/10ML (EQ 1MG BASE/ML) Prescription No No AP 2023/08/22 ZYDUS PHARMS
216249 003 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 10MG BASE/10ML (EQ 1MG BASE/ML) Prescription No No AP 2023/09/01 GLAND
214597 001 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 10MG BASE/10ML (EQ 1MG BASE/ML) Prescription No No AP 2024/07/05 NIVAGEN PHARMS INC
218059 002 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 10MG BASE/10ML (EQ 1MG BASE/ML) Prescription No No AP 2024/10/28 APOTEX
219585 001 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 10MG BASE/10ML (EQ 1MG BASE/ML) Prescription No No AP 2025/05/01 ASPIRO
217624 001 ANDA ZINC SULFATE ZINC SULFATE SOLUTION;INTRAVENOUS EQ 10MG BASE/10ML (EQ 1MG BASE/ML) Prescription No No AP 2025/06/10 RK PHARMA
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药品NDC数据与药品包装、标签说明书
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