药品注册申请号：010187
申请类型：NDA (新药申请)
申请人：SANDOZ
申请人全名：SANDOZ 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
003 RITALIN METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Yes No AB 1955/12/05 Approved Prior to Jan 1, 1982 Prescription
006 RITALIN METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Yes No AB Approved Prior to Jan 1, 1982 Prescription
010 RITALIN METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Yes Yes AB Approved Prior to Jan 1, 1982 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-96（补充） Approval Labeling STANDARD
2023/10/13 SUPPL-92（补充） Approval Labeling STANDARD
2021/06/26 SUPPL-93（补充） Approval Labeling 901 REQUIRED
2019/11/19 SUPPL-91（补充） Approval Labeling STANDARD
2019/01/10 SUPPL-82（补充） Approval Labeling STANDARD
2019/01/10 SUPPL-71（补充） Approval Labeling STANDARD
2017/01/04 SUPPL-87（补充） Approval Labeling 901 REQUIRED
2016/05/27 SUPPL-84（补充） Approval Manufacturing (CMC) STANDARD
2015/10/02 SUPPL-81（补充） Approval Manufacturing (CMC) STANDARD
2015/04/17 SUPPL-80（补充） Approval Labeling 901 REQUIRED
2014/07/14 SUPPL-78（补充） Approval Manufacturing (CMC) STANDARD
2014/02/07 SUPPL-76（补充） Approval Manufacturing (CMC) STANDARD
2013/12/13 SUPPL-77（补充） Approval Labeling STANDARD
2013/10/25 SUPPL-75（补充） Approval Manufacturing (CMC) STANDARD
2013/06/07 SUPPL-74（补充） Approval Labeling STANDARD
2010/12/09 SUPPL-73（补充） Approval Labeling STANDARD
2010/11/15 SUPPL-72（补充） Approval Labeling UNKNOWN
2007/04/25 SUPPL-69（补充） Approval Labeling STANDARD
2006/08/08 SUPPL-67（补充） Approval Labeling STANDARD
2006/08/08 SUPPL-66（补充） Approval Labeling STANDARD
2004/05/21 SUPPL-58（补充） Approval Labeling STANDARD
2004/05/21 SUPPL-57（补充） Approval Labeling STANDARD
2002/06/12 SUPPL-62（补充） Approval Manufacturing (CMC) STANDARD
2002/05/29 SUPPL-61（补充） Approval Manufacturing (CMC) STANDARD
2002/01/11 SUPPL-60（补充） Approval Labeling STANDARD
2001/08/15 SUPPL-59（补充） Approval Manufacturing (CMC) STANDARD
2000/01/11 SUPPL-56（补充） Approval Manufacturing (CMC) STANDARD
1999/04/13 SUPPL-55（补充） Approval Manufacturing (CMC) STANDARD
1998/11/24 SUPPL-54（补充） Approval Manufacturing (CMC) STANDARD
1998/09/17 SUPPL-53（补充） Approval Manufacturing (CMC) STANDARD
1998/08/12 SUPPL-52（补充） Approval Manufacturing (CMC) STANDARD
1998/04/24 SUPPL-51（补充） Approval Manufacturing (CMC) STANDARD
1998/02/20 SUPPL-50（补充） Approval Labeling STANDARD
1997/07/09 SUPPL-48（补充） Approval Labeling STANDARD
1997/07/09 SUPPL-46（补充） Approval Labeling STANDARD
1997/07/09 SUPPL-42（补充） Approval Labeling
1997/07/09 SUPPL-39（补充） Approval Labeling
1995/12/15 SUPPL-47（补充） Approval Labeling STANDARD
1995/06/01 SUPPL-45（补充） Approval Manufacturing (CMC) STANDARD
1994/08/19 SUPPL-44（补充） Approval Manufacturing (CMC) STANDARD
1994/05/31 SUPPL-43（补充） Approval Manufacturing (CMC) STANDARD
1994/03/07 SUPPL-41（补充） Approval Manufacturing (CMC) STANDARD
1990/03/09 SUPPL-40（补充） Approval Manufacturing (CMC) STANDARD
1987/12/08 SUPPL-38（补充） Approval Manufacturing (CMC) STANDARD
1986/01/21 SUPPL-37（补充） Approval Labeling
1985/10/10 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
1985/03/13 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
1981/02/18 SUPPL-32（补充） Approval Labeling
1980/03/06 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
1980/02/15 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
1979/10/12 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
1975/09/09 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
1975/09/09 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
1975/09/09 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1975/09/09 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1975/02/21 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1955/12/05 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
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;ORAL 规格:5MG 治疗等效代码:AB
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
010187 003 NDA RITALIN METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 SANDOZ
040300 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 1998/11/27 SPECGX LLC
090710 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2012/03/15 SUN PHARM INDS INC
091159 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2014/03/12 MOUNTAIN
202892 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2014/09/23 OXFORD PHARMS
207416 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/09/22 ASCENT PHARMS INC
207884 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/11/13 NOVEL LABS INC
206932 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2017/05/11 ABHAI INC
209753 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2018/03/02 BIONPHARMA
208737 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2019/02/01 CEDIPROF INC
211779 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2019/10/04 ALKEM LABS LTD
212697 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2020/07/23 PRINSTON INC
213936 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2020/10/28 ACCORD HLTHCARE
活性成分:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 治疗等效代码:AB
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
010187 006 NDA RITALIN METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription Yes No AB Approved Prior to Jan 1, 1982 SANDOZ
040300 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1998/11/27 SPECGX LLC
090710 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2012/03/15 SUN PHARM INDS INC
091159 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2014/03/12 MOUNTAIN
202892 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2014/09/23 OXFORD PHARMS
207416 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/09/22 ASCENT PHARMS INC
207884 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/11/13 NOVEL LABS INC
206932 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2017/05/11 ABHAI INC
209753 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2018/03/02 BIONPHARMA
208737 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2019/02/01 CEDIPROF INC
211779 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2019/10/04 ALKEM LABS LTD
212697 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/07/23 PRINSTON INC
213936 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/10/28 ACCORD HLTHCARE
活性成分:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:20MG 治疗等效代码:AB
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
010187 010 NDA RITALIN METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 SANDOZ
040300 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 1998/11/27 SPECGX LLC
090710 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2012/03/15 SUN PHARM INDS INC
091159 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2014/03/12 MOUNTAIN
202892 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2014/09/23 OXFORD PHARMS
207416 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2015/09/22 ASCENT PHARMS INC
207884 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2015/11/13 NOVEL LABS INC
206932 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2017/05/11 ABHAI INC
209753 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2018/03/02 BIONPHARMA
208737 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/02/01 CEDIPROF INC
211779 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/10/04 ALKEM LABS LTD
212697 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2020/07/23 PRINSTON INC
213936 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2020/10/28 ACCORD HLTHCARE
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database