药品注册申请号:214193
申请类型:ANDA (仿制药申请)
申请人:AMNEAL
申请人全名:AMNEAL EU LTD
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 PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 1% No No AT 2020/09/21 2020/09/21 Prescription
002 PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 2% No No AT 2020/09/21 Prescription
003 PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 4% No No AT 2020/09/21 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
2020/09/21 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:PILOCARPINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;OPHTHALMIC 规格:1% 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
200890 001 NDA ISOPTO CARPINE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 1% Prescription Yes Yes AT 2010/06/22 SANDOZ
204398 001 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 1% Prescription No No AT 2017/09/27 AKORN
210384 001 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 1% Prescription No No AT 2019/11/25 SOMERSET THERAPS LLC
214193 001 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 1% Prescription No No AT 2020/09/21 AMNEAL
活性成分:PILOCARPINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;OPHTHALMIC 规格:2% 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
200890 002 NDA ISOPTO CARPINE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 2% Prescription Yes Yes AT 2010/06/22 SANDOZ
204398 002 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 2% Prescription No No AT 2017/09/27 AKORN
210384 002 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 2% Prescription No No AT 2019/11/25 SOMERSET THERAPS LLC
214193 002 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 2% Prescription No No AT 2020/09/21 AMNEAL
活性成分:PILOCARPINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;OPHTHALMIC 规格:4% 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
200890 003 NDA ISOPTO CARPINE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 4% Prescription Yes Yes AT 2010/06/22 SANDOZ
204398 003 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 4% Prescription No No AT 2017/09/27 AKORN
210384 003 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 4% Prescription No No AT 2019/11/25 SOMERSET THERAPS LLC
214193 003 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC 4% Prescription No No AT 2020/09/21 AMNEAL
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