药品注册申请号:021146
申请类型:NDA (新药申请)
申请人:HOSPIRA
申请人全名:HOSPIRA 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 ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.5MG/5ML (0.1MG/ML) Yes Yes AP 2001/07/09 2001/07/09 Prescription
002 ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.25MG/5ML (0.05MG/ML) Yes Yes AP 2001/07/09 Prescription
003 ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/10ML (0.1MG/ML) Yes Yes AP 2001/07/09 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
2020/11/30 SUPPL-25(补充) Approval Manufacturing (CMC) N/A
2020/06/24 SUPPL-22(补充) Approval Labeling STANDARD
2017/11/01 SUPPL-19(补充) Approval Labeling STANDARD
2017/08/17 SUPPL-18(补充) Approval Manufacturing (CMC) N/A
2017/01/31 SUPPL-16(补充) Approval Labeling STANDARD
2015/10/30 SUPPL-15(补充) Approval Labeling STANDARD
2014/03/12 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
2001/07/09 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
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:ATROPINE SULFATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:0.5MG/5ML (0.1MG/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
021146 001 NDA ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.5MG/5ML (0.1MG/ML) Prescription Yes Yes AP 2001/07/09 HOSPIRA
212868 002 ANDA ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.5MG/5ML (0.1MG/ML) Prescription No No AP 2021/07/26 ACCORD HLTHCARE
215342 001 ANDA ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.5MG/5ML (0.1MG/ML) Prescription No No AP 2022/01/26 AMNEAL
活性成分:ATROPINE SULFATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:0.25MG/5ML (0.05MG/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
021146 002 NDA ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.25MG/5ML (0.05MG/ML) Prescription Yes Yes AP 2001/07/09 HOSPIRA
212868 001 ANDA ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.25MG/5ML (0.05MG/ML) Prescription No No AP 2021/07/26 ACCORD HLTHCARE
活性成分:ATROPINE SULFATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:1MG/10ML (0.1MG/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
021146 003 NDA ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/10ML (0.1MG/ML) Prescription Yes Yes AP 2001/07/09 HOSPIRA
212461 001 ANDA ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/10ML (0.1MG/ML) Prescription No No AP 2020/10/05 INTL MEDICATION SYS
212868 003 ANDA ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/10ML (0.1MG/ML) Prescription No No AP 2021/07/26 ACCORD HLTHCARE
214970 001 ANDA ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/10ML (0.1MG/ML) Prescription No No AP 2022/11/04 MEDEFIL INC
215342 002 ANDA ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/10ML (0.1MG/ML) Prescription No No AP 2023/10/25 AMNEAL
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