药品注册申请号：021259
申请类型：NDA (新药申请)
申请人：AYTU BIOPHARMA
申请人全名：AYTU BIOPHARMA 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 METADATE CD METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Yes No AB2 2001/04/03 2001/04/03 Prescription
002 METADATE CD METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Yes No AB2 2003/06/19 Prescription
003 METADATE CD METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Yes No AB2 2003/05/27 Prescription
004 METADATE CD METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Yes No AB2 2006/02/19 Prescription
005 METADATE CD METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 50MG Yes No AB2 2006/02/19 Prescription
006 METADATE CD METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 60MG Yes Yes AB2 2006/02/19 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
2023/10/13 SUPPL-34（补充） Approval Labeling STANDARD
2022/04/22 SUPPL-25（补充） Approval Labeling STANDARD
2021/06/25 SUPPL-32（补充） Approval Labeling 901 REQUIRED
2017/01/04 SUPPL-30（补充） Approval Labeling 901 REQUIRED
2015/06/15 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
2015/04/17 SUPPL-29（补充） Approval Labeling 901 REQUIRED
2013/12/13 SUPPL-27（补充） Approval Labeling STANDARD
2013/06/04 SUPPL-26（补充） Approval Labeling STANDARD
2013/05/06 SUPPL-24（补充） Approval Labeling STANDARD
2013/05/06 SUPPL-23（补充） Approval Labeling STANDARD
2010/10/18 SUPPL-22（补充） Approval Labeling UNKNOWN
2009/04/16 SUPPL-21（补充） Approval Labeling STANDARD
2008/08/26 SUPPL-19（补充） Approval Labeling STANDARD
2007/05/04 SUPPL-20（补充） Approval Labeling STANDARD
2006/08/10 SUPPL-18（补充） Approval Labeling STANDARD
2006/02/19 SUPPL-17（补充） Approval Manufacturing (CMC) N/A
2003/09/22 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
2003/06/19 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
2003/05/27 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
2002/11/06 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
2002/11/06 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
2002/09/18 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
2002/04/09 SUPPL-1（补充） Approval Labeling STANDARD
2001/04/03 ORIG-1（原始申请） Approval Type 3 - New Dosage Form 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
001 6344215 2020/10/27 Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 6344215 2020/10/27 Y PDF格式**本条是由Drugfuture回溯的历史信息**
003 6344215 2020/10/27 Y PDF格式**本条是由Drugfuture回溯的历史信息**
004 6344215 2020/10/27 Y PDF格式**本条是由Drugfuture回溯的历史信息**
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: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: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: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 Prescription 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 Prescription 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 Prescription 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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