药品注册申请号:205029
申请类型:NDA (新药申请)
申请人:BPI LABS
申请人全名:BPI LABS 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 EPINEPHRINE EPINEPHRINE SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 1MG/ML (1MG/ML) Yes Yes AP 2014/07/29 2014/07/29 Prescription
002 EPINEPHRINE EPINEPHRINE SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 10MG/10ML (1MG/ML) Yes Yes None 2022/02/04 Prescription
003 EPINEPHRINE EPINEPHRINE SOLUTION;INTRAVENOUS 1MG/ML (1MG/ML) Yes No None 2023/05/12 Discontinued
004 EPINEPHRINE EPINEPHRINE SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 30MG/30ML (1MG/ML) Yes Yes None 2024/02/14 Prescription
005 EPINEPHRINE EPINEPHRINE SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 1MG/ML (1MG/ML) Yes Yes None 2024/03/04 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
2024/03/04 SUPPL-12(补充) Approval Manufacturing (CMC) UNKNOWN
2023/12/28 SUPPL-13(补充) Approval Manufacturing (CMC) N/A
2023/05/12 SUPPL-10(补充) Approval Manufacturing (CMC) N/A
2022/02/04 SUPPL-9(补充) Approval Manufacturing (CMC) N/A
2021/09/10 SUPPL-6(补充) Approval Labeling STANDARD
2021/06/23 SUPPL-8(补充) Approval Labeling STANDARD
2016/05/18 SUPPL-4(补充) Approval Labeling 901 REQUIRED
2016/02/11 SUPPL-2(补充) Approval Efficacy STANDARD
2015/12/03 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
2015/10/23 SUPPL-1(补充) Approval Efficacy STANDARD
2014/07/29 ORIG-1(原始申请) Approval Type 7 - Drug Already Marketed without Approved NDA 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
001 10004700 2034/08/14 Y U-2325 Y 2018/06/29 PDF格式
10039728 2034/08/14 U-1828 Y 2018/08/07 PDF格式
9283197 2034/08/15 Y U-1830 U-1829 U-1828 Y 2016/04/07 PDF格式
001 10004700 2034/08/14 Y U-2325 PDF格式**本条是由Drugfuture回溯的历史信息**
10039728 2034/08/14 U-1828 PDF格式**本条是由Drugfuture回溯的历史信息**
9283197 2034/08/15 Y U-1828 U-1830 U-1829 PDF格式**本条是由Drugfuture回溯的历史信息**
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:EPINEPHRINE 剂型/给药途径:SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 规格:1MG/ML (1MG/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
205029 001 NDA EPINEPHRINE EPINEPHRINE SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 1MG/ML (1MG/ML) Prescription Yes Yes AP 2014/07/29 BPI LABS
213708 001 ANDA EPINEPHRINE EPINEPHRINE SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 1MG/ML (1MG/ML) Prescription No No AP 2024/11/20 FRESENIUS KABI USA
更多信息
药品NDC数据与药品包装、标签说明书
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