药品注册申请号：203583
申请类型：ANDA (仿制药申请)
申请人：SPECGX LLC
申请人全名：SPECGX 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 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG No No AB2 2015/09/29 2015/09/29 Prescription
002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG No No AB2 2015/09/29 Prescription
003 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG No No AB2 2015/09/29 Prescription
004 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG No No AB2 2015/09/29 Prescription
005 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 50MG No No AB2 2015/09/29 Prescription
006 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 60MG No No AB2 2015/09/29 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
2015/09/29 ORIG-1（原始申请） Approval
>>>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
2024/10/07 SUPPL-13（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2024/10/07 SUPPL-12（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2024/10/07 SUPPL-11（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2024/10/07 SUPPL-7（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2016/10/28 SUPPL-3（补充） Approval 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:CAPSULE, EXTENDED RELEASE;ORAL; 规格:10MG; 治疗等效代码:AB2<<<
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
021259 003 NDA METADATE CD METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription Yes No AB2 2003/05/27 AYTU BIOPHARMA
077707 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB2 2012/07/19 TEVA PHARMS
203583 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB2 2015/09/29 SPECGX LLC
205105 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB2 2016/07/28 IMPAX LABS INC
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:20MG; 治疗等效代码:AB2<<<
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
021259 001 NDA METADATE CD METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription Yes No AB2 2001/04/03 AYTU BIOPHARMA
077707 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription No No AB2 2012/07/19 TEVA PHARMS
203583 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription No No AB2 2015/09/29 SPECGX LLC
205105 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription No No AB2 2016/07/28 IMPAX LABS INC
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:30MG; 治疗等效代码:AB2<<<
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
021259 002 NDA METADATE CD METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription Yes No AB2 2003/06/19 AYTU BIOPHARMA
077707 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription No No AB2 2012/07/19 TEVA PHARMS
203583 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription No No AB2 2015/09/29 SPECGX LLC
205105 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription No No AB2 2016/07/28 IMPAX LABS INC
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:40MG; 治疗等效代码:AB2<<<
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
021259 004 NDA METADATE CD METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Prescription Yes No AB2 2006/02/19 AYTU BIOPHARMA
078873 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Discontinued No No AB2 2012/07/19 TEVA PHARMS
203583 004 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Prescription No No AB2 2015/09/29 SPECGX LLC
205105 004 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Prescription No No AB2 2016/07/28 IMPAX LABS INC
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:50MG; 治疗等效代码:AB2<<<
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
021259 005 NDA METADATE CD METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription Yes No AB2 2006/02/19 AYTU BIOPHARMA
078873 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 50MG Discontinued No No AB2 2012/07/19 TEVA PHARMS
203583 005 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB2 2015/09/29 SPECGX LLC
205105 005 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 50MG Prescription No No AB2 2016/07/28 IMPAX LABS INC
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:60MG; 治疗等效代码:AB2<<<
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
021259 006 NDA METADATE CD METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 60MG Prescription Yes Yes AB2 2006/02/19 AYTU BIOPHARMA
078873 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 60MG Discontinued No No AB2 2012/07/19 TEVA PHARMS
203583 006 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 60MG Prescription No No AB2 2015/09/29 SPECGX LLC
205105 006 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 60MG Prescription No No AB2 2016/07/28 IMPAX LABS INC
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药品NDC数据与药品包装、标签说明书
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