药品注册申请号：204300
申请类型：NDA (新药申请)
申请人：EXELA PHARMA
申请人全名：EXELA PHARMA SCIENCES 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 VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Yes Yes AP1 2014/06/27 2014/06/27 Prescription
002 VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Yes Yes AP1 2014/06/27 Prescription
003 VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Yes Yes AP1 2014/06/27 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
2020/03/20 SUPPL-11（补充） Approval Labeling STANDARD
2019/10/18 SUPPL-8（补充） Approval Labeling STANDARD
2015/10/29 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
2015/05/28 SUPPL-5（补充） Approval Labeling STANDARD
2015/01/02 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
2014/06/27 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer 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:PHENYLEPHRINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:10MG/ML (10MG/ML) 治疗等效代码:AP1
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
204300 001 NDA VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription Yes Yes AP1 2014/06/27 EXELA PHARMA
211079 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2018/07/05 AMNEAL
208905 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2019/01/31 SANDOZ
209967 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2020/01/16 SAGENT PHARMS INC
213318 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2020/06/11 CAPLIN
213237 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Discontinued No No AP1 2020/07/01 ACCORD HLTHCARE
211081 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2020/07/17 PROVEPHARM SAS
211920 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2021/04/08 GLAND PHARMA LTD
217069 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2022/08/30 MANKIND PHARMA
218412 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Discontinued No No AP1 2024/03/14 HAINAN POLY
218110 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2024/05/10 ASPIRO
活性成分:PHENYLEPHRINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:50MG/5ML (10MG/ML) 治疗等效代码:AP1
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
204300 002 NDA VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription Yes Yes AP1 2014/06/27 EXELA PHARMA
210333 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP1 2018/04/27 MEITHEAL
211078 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP1 2018/07/19 AMNEAL
210025 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP1 2018/12/21 ENDO OPERATIONS
210666 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP1 2019/01/30 FRESENIUS KABI USA
208905 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP1 2019/01/31 SANDOZ
209967 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP1 2020/01/16 SAGENT PHARMS INC
211920 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP1 2020/06/05 GLAND PHARMA LTD
213318 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP1 2020/06/11 CAPLIN
213237 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Discontinued No No AP1 2020/07/01 ACCORD HLTHCARE
211081 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP1 2020/07/17 PROVEPHARM SAS
210697 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP1 2020/11/13 EUGIA PHARMA
217069 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP1 2022/08/30 MANKIND PHARMA
218412 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Discontinued No No AP1 2024/03/14 HAINAN POLY
218110 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP1 2024/05/10 ASPIRO
活性成分:PHENYLEPHRINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:100MG/10ML (10MG/ML) 治疗等效代码:AP1
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
204300 003 NDA VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription Yes Yes AP1 2014/06/27 EXELA PHARMA
210333 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2018/04/27 MEITHEAL
211078 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2018/07/19 AMNEAL
210025 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2018/12/21 ENDO OPERATIONS
210666 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2019/01/30 FRESENIUS KABI USA
208905 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2019/01/31 SANDOZ
209967 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2020/01/16 SAGENT PHARMS INC
211920 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2020/06/05 GLAND PHARMA LTD
213318 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2020/06/11 CAPLIN
213237 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Discontinued No No AP1 2020/07/01 ACCORD HLTHCARE
211081 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2020/07/17 PROVEPHARM SAS
210697 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2020/11/13 EUGIA PHARMA
217069 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2022/08/30 MANKIND PHARMA
218412 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Discontinued No No AP1 2024/03/14 HAINAN POLY
218110 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2024/05/10 ASPIRO
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