药品注册申请号:209784
申请类型:ANDA (仿制药申请)
申请人:SANDOZ
申请人全名:SANDOZ 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 EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) No No AP 2017/08/23 2017/08/23 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
2020/11/24 SUPPL-2(补充) Approval Labeling STANDARD
2019/10/28 SUPPL-1(补充) Approval Labeling STANDARD
2017/08/23 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:EPHEDRINE SULFATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:50MG/ML (50MG/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
208289 001 NDA AKOVAZ EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Prescription Yes Yes AP 2016/04/29 EXELA PHARMA
208943 001 NDA CORPHEDRA EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Prescription No No AP 2017/01/27 PAR STERILE PRODUCTS
208609 001 NDA EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Discontinued No No AP 2017/03/01 RENEW PHARMS
209784 001 ANDA EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Prescription No No AP 2017/08/23 SANDOZ
212932 001 ANDA EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Prescription No No AP 2019/10/23 AMNEAL
209646 001 ANDA EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Prescription No No AP 2020/08/04 FRESENIUS KABI USA
212649 001 ANDA EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Prescription No No AP 2020/10/03 DR REDDYS
214334 001 ANDA EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Prescription No No AP 2020/12/15 HIKMA
214579 001 ANDA EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Prescription No No AP 2021/06/14 EUGIA PHARMA
216146 001 ANDA EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Prescription No No AP 2022/02/25 GLAND PHARMA LTD
216129 001 ANDA EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Prescription No No AP 2022/04/14 MANKIND PHARMA
215825 001 ANDA EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Prescription No No AP 2022/04/21 XIROMED
214528 001 ANDA EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Prescription No No AP 2023/03/09 SAGENT PHARMS INC
217276 001 ANDA EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Discontinued No No AP 2023/05/16 ZYDUS PHARMS
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