药品注册申请号：212037
申请类型：ANDA (仿制药申请)
申请人：ELITE LABS INC
申请人全名：ELITE 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 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG No No AB1 2019/12/11 2019/12/11 Prescription
002 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG No No AB1 2019/12/11 Prescription
003 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG No No AB1 2019/12/11 Prescription
004 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG No No AB1 2019/12/11 Prescription
005 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG No No AB1 2019/12/11 Prescription
006 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG No No AB1 2019/12/11 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
2024/04/01 SUPPL-7（补充） Approval Labeling STANDARD
2019/12/11 ORIG-1（原始申请） Approval 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:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:1.25MG;1.25MG;1.25MG;1.25MG 治疗等效代码:AB1
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
021303 005 NDA ADDERALL XR 5 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription Yes No AB1 2002/05/22 TAKEDA PHARMS USA
077302 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB1 2012/06/22 ACTAVIS ELIZABETH
076852 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB1 2016/02/16 IMPAX LABS
205401 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB1 2019/01/22 ANI PHARMS
211547 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB1 2019/04/22 SPECGX LLC
211715 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Discontinued No No AB1 2019/05/17 SUN PHARM INDUSTRIES
210651 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB1 2019/05/17 RHODES PHARMS
212037 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB1 2019/12/11 ELITE LABS INC
214959 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB1 2021/09/29 ASCENT PHARMS INC
214403 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB1 2021/11/26 LANNETT CO INC
217027 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB1 2023/01/23 GRANULES
214777 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG Prescription No No AB1 2024/11/07 LUPIN
活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:2.5MG;2.5MG;2.5MG;2.5MG 治疗等效代码:AB1
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
021303 001 NDA ADDERALL XR 10 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription Yes No AB1 2001/10/11 TAKEDA PHARMS USA
077302 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB1 2012/06/22 ACTAVIS ELIZABETH
076852 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB1 2016/02/16 IMPAX LABS
205401 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB1 2019/01/22 ANI PHARMS
211547 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB1 2019/04/22 SPECGX LLC
211715 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Discontinued No No AB1 2019/05/17 SUN PHARM INDUSTRIES
210651 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB1 2019/05/17 RHODES PHARMS
212037 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB1 2019/12/11 ELITE LABS INC
214959 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB1 2021/09/29 ASCENT PHARMS INC
214403 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB1 2021/11/26 LANNETT CO INC
217027 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB1 2023/01/23 GRANULES
214777 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG Prescription No No AB1 2024/11/07 LUPIN
活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:3.75MG;3.75MG;3.75MG;3.75MG 治疗等效代码:AB1
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
021303 006 NDA ADDERALL XR 15 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Prescription Yes No AB1 2002/05/22 TAKEDA PHARMS USA
077302 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Prescription No No AB1 2012/06/22 ACTAVIS ELIZABETH
076852 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Prescription No No AB1 2016/02/16 IMPAX LABS
205401 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Prescription No No AB1 2019/01/22 ANI PHARMS
211547 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Prescription No No AB1 2019/04/22 SPECGX LLC
211715 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Discontinued No No AB1 2019/05/17 SUN PHARM INDUSTRIES
210651 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Prescription No No AB1 2019/05/17 RHODES PHARMS
212037 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Prescription No No AB1 2019/12/11 ELITE LABS INC
214959 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Prescription No No AB1 2021/09/29 ASCENT PHARMS INC
214403 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Prescription No No AB1 2021/11/26 LANNETT CO INC
217027 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Prescription No No AB1 2023/01/23 GRANULES
214777 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG Prescription No No AB1 2024/11/07 LUPIN
活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:5MG;5MG;5MG;5MG 治疗等效代码:AB1
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
021303 002 NDA ADDERALL XR 20 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Prescription Yes No AB1 2001/10/11 TAKEDA PHARMS USA
077302 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Prescription No No AB1 2012/06/22 ACTAVIS ELIZABETH
076852 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Prescription No No AB1 2016/02/16 IMPAX LABS
205401 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Prescription No No AB1 2019/01/22 ANI PHARMS
211547 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Prescription No No AB1 2019/04/22 SPECGX LLC
211715 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Discontinued No No AB1 2019/05/17 SUN PHARM INDUSTRIES
210651 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Prescription No No AB1 2019/05/17 RHODES PHARMS
212037 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Prescription No No AB1 2019/12/11 ELITE LABS INC
214959 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Prescription No No AB1 2021/09/29 ASCENT PHARMS INC
214403 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Prescription No No AB1 2021/11/26 LANNETT CO INC
217027 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Prescription No No AB1 2023/01/23 GRANULES
214777 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG;5MG;5MG;5MG Prescription No No AB1 2024/11/07 LUPIN
活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:6.25MG;6.25MG;6.25MG;6.25MG 治疗等效代码:AB1
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
021303 004 NDA ADDERALL XR 25 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription Yes No AB1 2002/05/22 TAKEDA PHARMS USA
077302 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB1 2012/06/22 ACTAVIS ELIZABETH
076852 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB1 2016/02/16 IMPAX LABS
205401 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB1 2019/01/22 ANI PHARMS
211547 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB1 2019/04/22 SPECGX LLC
211715 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Discontinued No No AB1 2019/05/17 SUN PHARM INDUSTRIES
210651 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB1 2019/05/17 RHODES PHARMS
212037 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB1 2019/12/11 ELITE LABS INC
214959 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB1 2021/09/29 ASCENT PHARMS INC
214403 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB1 2021/11/26 LANNETT CO INC
217027 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB1 2023/01/23 GRANULES
214777 005 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB1 2024/11/07 LUPIN
活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:7.5MG;7.5MG;7.5MG;7.5MG 治疗等效代码:AB1
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
021303 003 NDA ADDERALL XR 30 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription Yes Yes AB1 2001/10/11 TAKEDA PHARMS USA
077302 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB1 2012/06/22 ACTAVIS ELIZABETH
076852 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB1 2016/02/16 IMPAX LABS
205401 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB1 2019/01/22 ANI PHARMS
211547 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB1 2019/04/22 SPECGX LLC
211715 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Discontinued No No AB1 2019/05/17 SUN PHARM INDUSTRIES
210651 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB1 2019/05/17 RHODES PHARMS
212037 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB1 2019/12/11 ELITE LABS INC
214959 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB1 2021/09/29 ASCENT PHARMS INC
214403 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB1 2021/11/26 LANNETT CO INC
217027 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB1 2023/01/23 GRANULES
214777 006 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 7.5MG;7.5MG;7.5MG;7.5MG Prescription No No AB1 2024/11/07 LUPIN
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