药品注册申请号：091695
申请类型：ANDA (仿制药申请)
申请人：LANNETT CO INC
申请人全名：LANNETT CO 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 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 18MG No No BX;BX 2013/07/09 2013/07/09 Prescription
002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 27MG No No BX;BX 2013/07/09 Prescription
003 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 36MG No No BX;BX 2013/09/23 Prescription
004 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 54MG No No BX;BX 2013/09/23 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2013/09/23 ORIG-2（原始申请） Approval Not Applicable
2013/07/09 ORIG-1（原始申请） Approval Not Applicable
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2013/12/31 SUPPL-2（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert 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
无
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
无
与本品治疗等效的药品
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:18MG; 治疗等效代码:BX<<<
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
091695 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 18MG Prescription No No BX 2013/07/09 LANNETT CO INC
207515 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 18MG Discontinued No No BX 2018/02/01 AMNEAL PHARMS
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:18MG; 治疗等效代码:BX<<<
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
091695 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 18MG Prescription No No BX 2013/07/09 LANNETT CO INC
207515 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 18MG Discontinued No No BX 2018/02/01 AMNEAL PHARMS
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:27MG; 治疗等效代码:BX<<<
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
202608 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 27MG Prescription No No BX 2012/12/28 SPECGX LLC
091695 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 27MG Prescription No No BX 2013/07/09 LANNETT CO INC
207515 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 27MG Discontinued No No BX 2018/02/01 AMNEAL PHARMS
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:27MG; 治疗等效代码:BX<<<
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
202608 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 27MG Prescription No No BX 2012/12/28 SPECGX LLC
091695 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 27MG Prescription No No BX 2013/07/09 LANNETT CO INC
207515 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 27MG Discontinued No No BX 2018/02/01 AMNEAL PHARMS
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:36MG; 治疗等效代码:BX<<<
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
202608 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 36MG Prescription No No BX 2012/12/28 SPECGX LLC
091695 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 36MG Prescription No No BX 2013/09/23 LANNETT CO INC
207515 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 36MG Discontinued No No BX 2018/02/01 AMNEAL PHARMS
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:36MG; 治疗等效代码:BX<<<
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
202608 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 36MG Prescription No No BX 2012/12/28 SPECGX LLC
091695 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 36MG Prescription No No BX 2013/09/23 LANNETT CO INC
207515 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 36MG Discontinued No No BX 2018/02/01 AMNEAL PHARMS
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:54MG; 治疗等效代码:BX<<<
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
202608 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 54MG Prescription No No BX 2012/12/28 SPECGX LLC
091695 004 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 54MG Prescription No No BX 2013/09/23 LANNETT CO INC
207515 004 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 54MG Discontinued No No BX 2018/02/01 AMNEAL PHARMS
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:54MG; 治疗等效代码:BX<<<
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
202608 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 54MG Prescription No No BX 2012/12/28 SPECGX LLC
091695 004 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 54MG Prescription No No BX 2013/09/23 LANNETT CO INC
207515 004 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 54MG Discontinued No No BX 2018/02/01 AMNEAL PHARMS
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