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 |
2024/07/26 |
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 |
与本品治疗等效的药品
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:CAPSULE;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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
021977 |
004 |
NDA |
VYVANSE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
Yes |
No |
AB |
2007/12/10
|
TAKEDA PHARMS USA |
202802 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Discontinued |
No |
No |
AB |
2023/08/25
|
ACTAVIS ELIZABETH |
202827 |
001 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/25
|
HIKMA |
202830 |
001 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/25
|
AMNEAL |
202835 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/25
|
MYLAN |
211840 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/25
|
SPECGX LLC |
214484 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/25
|
SUN PHARM INDS INC |
214547 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/25
|
NORWICH |
215330 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/25
|
RHODES PHARMS |
215802 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/25
|
LANNETT CO INC |
216266 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/25
|
PRINSTON INC |
216944 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/25
|
APOTEX |
217194 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/25
|
ALKEM LABS LTD |
217442 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/25
|
ASCENT PHARMS INC |
202836 |
001 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2024/07/26
|
SANDOZ |
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:CAPSULE;ORAL 规格:30MG 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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
021977 |
001 |
NDA |
VYVANSE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
Yes |
No |
AB |
2007/02/23
|
TAKEDA PHARMS USA |
202802 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Discontinued |
No |
No |
AB |
2023/08/25
|
ACTAVIS ELIZABETH |
202827 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/25
|
HIKMA |
202830 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/25
|
AMNEAL |
202835 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/25
|
MYLAN |
211840 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/25
|
SPECGX LLC |
214484 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/25
|
SUN PHARM INDS INC |
214547 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/25
|
NORWICH |
215330 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/25
|
RHODES PHARMS |
215802 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/25
|
LANNETT CO INC |
216266 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/25
|
PRINSTON INC |
216944 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/25
|
APOTEX |
217194 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/25
|
ALKEM LABS LTD |
217442 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/25
|
ASCENT PHARMS INC |
202836 |
002 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2024/07/26
|
SANDOZ |
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:CAPSULE;ORAL 规格:40MG 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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
021977 |
005 |
NDA |
VYVANSE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
Yes |
No |
AB |
2007/12/10
|
TAKEDA PHARMS USA |
202802 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Discontinued |
No |
No |
AB |
2023/08/25
|
ACTAVIS ELIZABETH |
202827 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/08/25
|
HIKMA |
202830 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/08/25
|
AMNEAL |
202835 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/08/25
|
MYLAN |
211840 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/08/25
|
SPECGX LLC |
214484 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/08/25
|
SUN PHARM INDS INC |
214547 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/08/25
|
NORWICH |
215330 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/08/25
|
RHODES PHARMS |
215802 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/08/25
|
LANNETT CO INC |
216266 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/08/25
|
PRINSTON INC |
216944 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/08/25
|
APOTEX |
217194 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/08/25
|
ALKEM LABS LTD |
217442 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/08/25
|
ASCENT PHARMS INC |
202836 |
003 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
40MG |
Prescription |
No |
No |
AB |
2024/07/26
|
SANDOZ |
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:CAPSULE;ORAL 规格:50MG 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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
021977 |
002 |
NDA |
VYVANSE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
Yes |
No |
AB |
2007/02/23
|
TAKEDA PHARMS USA |
202802 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Discontinued |
No |
No |
AB |
2023/08/25
|
ACTAVIS ELIZABETH |
202827 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/08/25
|
HIKMA |
202830 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/08/25
|
AMNEAL |
202835 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/08/25
|
MYLAN |
211840 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/08/25
|
SPECGX LLC |
214484 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/08/25
|
SUN PHARM INDS INC |
214547 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/08/25
|
NORWICH |
215330 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/08/25
|
RHODES PHARMS |
215802 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/08/25
|
LANNETT CO INC |
216266 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/08/25
|
PRINSTON INC |
216944 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/08/25
|
APOTEX |
217194 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/08/25
|
ALKEM LABS LTD |
217442 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/08/25
|
ASCENT PHARMS INC |
202836 |
004 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2024/07/26
|
SANDOZ |
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:CAPSULE;ORAL 规格:60MG 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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
021977 |
006 |
NDA |
VYVANSE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
Yes |
No |
AB |
2007/12/10
|
TAKEDA PHARMS USA |
202802 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Discontinued |
No |
No |
AB |
2023/08/25
|
ACTAVIS ELIZABETH |
202827 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2023/08/25
|
HIKMA |
202830 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2023/08/25
|
AMNEAL |
202835 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2023/08/25
|
MYLAN |
211840 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2023/08/25
|
SPECGX LLC |
214484 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2023/08/25
|
SUN PHARM INDS INC |
214547 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2023/08/25
|
NORWICH |
215330 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2023/08/25
|
RHODES PHARMS |
215802 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2023/08/25
|
LANNETT CO INC |
216266 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2023/08/25
|
PRINSTON INC |
216944 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2023/08/25
|
APOTEX |
217194 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2023/08/25
|
ALKEM LABS LTD |
217442 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2023/08/25
|
ASCENT PHARMS INC |
202836 |
005 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2024/07/26
|
SANDOZ |
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:CAPSULE;ORAL 规格:70MG 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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
021977 |
003 |
NDA |
VYVANSE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
Yes |
Yes |
AB |
2007/02/23
|
TAKEDA PHARMS USA |
202802 |
007 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Discontinued |
No |
No |
AB |
2023/08/25
|
ACTAVIS ELIZABETH |
202827 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2023/08/25
|
HIKMA |
202830 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2023/08/25
|
AMNEAL |
202835 |
007 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2023/08/25
|
MYLAN |
211840 |
007 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2023/08/25
|
SPECGX LLC |
214484 |
007 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2023/08/25
|
SUN PHARM INDS INC |
214547 |
007 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2023/08/25
|
NORWICH |
215330 |
007 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2023/08/25
|
RHODES PHARMS |
215802 |
007 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2023/08/25
|
LANNETT CO INC |
216266 |
007 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2023/08/25
|
PRINSTON INC |
216944 |
007 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2023/08/25
|
APOTEX |
217194 |
007 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2023/08/25
|
ALKEM LABS LTD |
217442 |
007 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2023/08/25
|
ASCENT PHARMS INC |
202836 |
006 |
ANDA |
LISDEXAMFETAMINE DIMESYLATE |
LISDEXAMFETAMINE DIMESYLATE |
CAPSULE;ORAL |
70MG |
Prescription |
No |
No |
AB |
2024/07/26
|
SANDOZ |