药品注册申请号:017078
申请类型:NDA (新药申请)
申请人:IMPAX LABS INC
申请人全名:IMPAX LABORATORIES 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 DEXEDRINE SPANSULE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG Yes No AB 1976/08/02 Approved Prior to Jan 1, 1982 Prescription
002 DEXEDRINE SPANSULE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 10MG Yes No AB Approved Prior to Jan 1, 1982 Prescription
003 DEXEDRINE SPANSULE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 15MG 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-55(补充) Approval Labeling STANDARD
2022/02/25 SUPPL-54(补充) Approval Labeling 901 REQUIRED
2019/01/15 SUPPL-52(补充) Approval Labeling STANDARD
2017/05/19 SUPPL-50(补充) Approval Labeling 901 REQUIRED
2017/01/04 SUPPL-49(补充) Approval Labeling 901 REQUIRED
2015/04/17 SUPPL-48(补充) Approval Labeling 901 REQUIRED
2013/12/06 SUPPL-47(补充) Approval Labeling STANDARD
2013/06/11 SUPPL-46(补充) Approval Labeling STANDARD
2008/05/23 SUPPL-44(补充) Approval Labeling STANDARD
2007/05/01 SUPPL-42(补充) Approval Labeling STANDARD
2006/08/10 SUPPL-40(补充) Approval Labeling STANDARD
2000/10/20 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
2000/04/13 SUPPL-37(补充) Approval Manufacturing (CMC) STANDARD
1999/11/03 SUPPL-34(补充) Approval Labeling STANDARD
1999/10/07 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
1999/10/07 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1998/12/03 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1998/06/12 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1998/04/06 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1998/04/06 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1997/07/09 SUPPL-27(补充) Approval Labeling STANDARD
1994/09/12 SUPPL-25(补充) Approval Labeling STANDARD
1993/07/21 SUPPL-22(补充) Approval Labeling
1987/12/16 SUPPL-21(补充) Approval Labeling
1987/12/02 SUPPL-20(补充) Approval Labeling
1983/02/22 SUPPL-17(补充) Approval Labeling
1982/08/25 SUPPL-19(补充) Approval Labeling
1982/08/25 SUPPL-18(补充) Approval Labeling
1980/10/06 SUPPL-16(补充) Approval Labeling
1980/09/19 SUPPL-15(补充) Approval Labeling
1980/08/29 SUPPL-14(补充) Approval Labeling
1980/08/29 SUPPL-13(补充) Approval Labeling
1980/08/29 SUPPL-12(补充) Approval Labeling
1980/04/16 SUPPL-11(补充) Approval Labeling
1979/08/30 SUPPL-9(补充) Approval Labeling
1979/06/27 SUPPL-8(补充) Approval Labeling
1979/06/06 SUPPL-7(补充) Approval Labeling
1979/03/30 SUPPL-5(补充) Approval Labeling
1979/03/30 SUPPL-3(补充) Approval Labeling
1976/08/02 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer 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:DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;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
017078 001 NDA DEXEDRINE SPANSULE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 IMPAX LABS INC
076353 001 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2003/05/06 SPECGX LLC
203901 001 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2012/11/30 ACTAVIS ELIZABETH
205673 001 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2017/10/31 STRIDES PHARMA
活性成分:DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;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
017078 002 NDA DEXEDRINE SPANSULE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription Yes No AB Approved Prior to Jan 1, 1982 IMPAX LABS INC
076353 002 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2003/05/06 SPECGX LLC
203901 002 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2012/11/30 ACTAVIS ELIZABETH
205673 002 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2017/10/31 STRIDES PHARMA
活性成分:DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:15MG 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
017078 003 NDA DEXEDRINE SPANSULE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 IMPAX LABS INC
076353 003 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2003/05/06 SPECGX LLC
203901 003 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2012/11/30 ACTAVIS ELIZABETH
205673 003 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2017/10/31 STRIDES PHARMA
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