药品注册申请号:207926
申请类型:NDA (新药申请)
申请人:ALCON
申请人全名:ALCON RESEARCH 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 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 2.5% Yes No AT 2015/01/15 2015/01/15 Prescription
002 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 10% Yes No AT 2015/01/15 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
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
2019/03/01 SUPPL-2(补充) Approval Labeling STANDARD
2015/01/15 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
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:PHENYLEPHRINE HYDROCHLORIDE 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:2.5% 治疗等效代码:AT
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
203510 001 NDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 2.5% Prescription Yes Yes AT 2013/03/21 PARAGON BIOTECK
207926 001 NDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 2.5% Prescription Yes No AT 2015/01/15 ALCON
216859 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 2.5% Prescription No Yes AT 2022/09/29 MANKIND PHARMA
215183 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 2.5% Prescription No No AT 2024/05/23 CAPLIN
活性成分:PHENYLEPHRINE HYDROCHLORIDE 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:10% 治疗等效代码:AT
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
203510 002 NDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 10% Prescription Yes Yes AT 2013/03/21 PARAGON BIOTECK
207926 002 NDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 10% Prescription Yes No AT 2015/01/15 ALCON
216496 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 10% Prescription No Yes AT 2023/01/11 MANKIND PHARMA
215183 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 10% Prescription No No AT 2024/05/23 CAPLIN
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