药品注册申请号：040439
申请类型：ANDA (仿制药申请)
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
001 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG No No AB 2002/06/14 2002/06/14 Prescription
002 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG No No AB 2002/06/14 Prescription
003 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG No No AB 2002/06/14 Prescription
004 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG No No AB 2002/09/27 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
2024/06/14 SUPPL-34（补充） Approval Labeling STANDARD
2023/10/13 SUPPL-32（补充） Approval Labeling STANDARD
2023/02/07 SUPPL-30（补充） Approval Labeling STANDARD
2022/02/25 SUPPL-29（补充） Approval Labeling STANDARD
2017/01/04 SUPPL-20（补充） Approval Labeling STANDARD
2015/04/17 SUPPL-18（补充） Approval Labeling STANDARD
2015/01/29 SUPPL-17（补充） Approval Labeling STANDARD
2015/01/29 SUPPL-15（补充） Approval Labeling STANDARD
2010/09/23 SUPPL-10（补充） Approval Labeling
2010/09/23 SUPPL-8（补充） Approval Labeling
2010/09/23 SUPPL-7（补充） Approval Labeling
2002/12/09 SUPPL-1（补充） Approval Manufacturing (CMC)
2002/06/14 ORIG-1（原始申请） Approval
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:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:2.5MG;2.5MG;2.5MG;2.5MG 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
040422 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2002/02/11 BARR
040439 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2002/06/14 SANDOZ
040444 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2002/06/19 EPIC PHARMA LLC
040480 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2003/09/09 SUN PHARM INDUSTRIES
040440 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2003/10/07 SPECGX LLC
202424 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2013/11/27 AUROLIFE PHARMA LLC
206340 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2016/02/05 ACTAVIS ELIZABETH
207388 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2017/07/28 ALVOGEN
207340 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2017/10/31 ZYDUS PHARMS
209799 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2017/12/28 NUVO PHARM
211352 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2018/12/07 ELITE LABS INC
210293 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2020/04/03 ORYZA
213111 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2021/01/13 RHODES PHARMS
213709 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2021/04/22 ASCENT PHARMS INC
214347 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Discontinued No No AB 2021/11/22 ACCORD HLTHCARE
215771 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2021/12/28 GRANULES
210754 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Discontinued No No AB 2022/07/05 CEDIPROF INC
215565 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2022/07/08 LANNETT CO INC
217787 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB 2023/10/06 ALKEM LABS LTD
活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:5MG;5MG;5MG;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
040422 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2002/02/11 BARR
040439 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2002/06/14 SANDOZ
040444 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2002/06/19 EPIC PHARMA LLC
040480 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2003/09/09 SUN PHARM INDUSTRIES
040440 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2003/10/07 SPECGX LLC
202424 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2013/11/27 AUROLIFE PHARMA LLC
206340 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2016/02/05 ACTAVIS ELIZABETH
207388 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2017/07/28 ALVOGEN
207340 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2017/10/31 ZYDUS PHARMS
209799 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2017/12/28 NUVO PHARM
211352 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2018/12/07 ELITE LABS INC
210293 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2020/04/03 ORYZA
213111 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2021/01/13 RHODES PHARMS
213709 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2021/04/22 ASCENT PHARMS INC
214347 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Discontinued No No AB 2021/11/22 ACCORD HLTHCARE
215771 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2021/12/28 GRANULES
210754 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Discontinued No No AB 2022/07/05 CEDIPROF INC
215565 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2022/07/08 LANNETT CO INC
217787 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG Prescription No No AB 2023/10/06 ALKEM LABS LTD
活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:7.5MG;7.5MG;7.5MG;7.5MG 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
040422 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No Yes AB 2002/02/11 BARR
040439 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2002/06/14 SANDOZ
040444 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2002/06/19 EPIC PHARMA LLC
040480 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2003/09/09 SUN PHARM INDUSTRIES
040440 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2003/10/07 SPECGX LLC
202424 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2013/11/27 AUROLIFE PHARMA LLC
206340 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2016/02/05 ACTAVIS ELIZABETH
207388 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2017/07/28 ALVOGEN
207340 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2017/10/31 ZYDUS PHARMS
209799 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2017/12/28 NUVO PHARM
211352 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2018/12/07 ELITE LABS INC
210293 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2020/04/03 ORYZA
213111 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2021/01/13 RHODES PHARMS
213709 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2021/04/22 ASCENT PHARMS INC
214347 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Discontinued No No AB 2021/11/22 ACCORD HLTHCARE
215771 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2021/12/28 GRANULES
210754 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Discontinued No No AB 2022/07/05 CEDIPROF INC
215565 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2022/07/08 LANNETT CO INC
217787 007 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB 2023/10/06 ALKEM LABS LTD
活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:1.25MG;1.25MG;1.25MG;1.25MG 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
040422 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2002/02/11 BARR
040444 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2002/06/19 EPIC PHARMA LLC
040439 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2002/09/27 SANDOZ
040480 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2003/09/09 SUN PHARM INDUSTRIES
040440 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2003/10/07 SPECGX LLC
202424 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2013/11/27 AUROLIFE PHARMA LLC
206340 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2016/02/05 ACTAVIS ELIZABETH
207388 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2017/07/28 ALVOGEN
207340 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2017/10/31 ZYDUS PHARMS
209799 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2017/12/28 NUVO PHARM
211352 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2018/12/07 ELITE LABS INC
210293 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2020/04/03 ORYZA
213111 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2021/01/13 RHODES PHARMS
213709 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2021/04/22 ASCENT PHARMS INC
214347 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Discontinued No No AB 2021/11/22 ACCORD HLTHCARE
215771 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2021/12/28 GRANULES
210754 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Discontinued No No AB 2022/07/05 CEDIPROF INC
215565 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2022/07/08 LANNETT CO INC
217787 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB 2023/10/06 ALKEM LABS LTD
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