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 |
|---|
| 2024/10/31 |
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 |
与本品治疗等效的药品
活性成分:CHOLESTYRAMINE 剂型/给药途径:POWDER;ORAL 规格:EQ 4GM RESIN/SCOOPFUL 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 |
|---|
| 074557 |
002 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
1996/08/15
|
EPIC PHARMA LLC |
| 074558 |
002 |
ANDA |
CHOLESTYRAMINE LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
1996/08/15
|
EPIC PHARMA LLC |
| 074561 |
002 |
ANDA |
LOCHOLEST |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
1996/08/15
|
CHARTWELL RX |
| 074562 |
002 |
ANDA |
LOCHOLEST LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
1996/08/15
|
CHARTWELL RX |
| 074554 |
002 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Discontinued |
No |
No |
AB |
1996/10/02
|
ANI PHARMS |
| 073263 |
002 |
ANDA |
PREVALITE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
1997/10/30
|
UPSHER SMITH LABS |
| 077203 |
002 |
ANDA |
CHOLESTYRAMINE LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
2005/08/26
|
ENDO OPERATIONS |
| 077204 |
002 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
2005/08/26
|
ENDO OPERATIONS |
| 202902 |
001 |
ANDA |
CHOLESTYRAMINE LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
2017/04/25
|
ZYDUS PHARMS |
| 202901 |
001 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
2018/07/02
|
ZYDUS PHARMS |
| 211119 |
002 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
2020/04/06
|
AJANTA PHARMA LTD |
| 209599 |
002 |
ANDA |
CHOLESTYRAMINE LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
2020/11/12
|
TAGI |
| 209597 |
002 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
2021/03/09
|
TAGI |
| 211799 |
002 |
ANDA |
CHOLESTYRAMINE LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
2021/10/19
|
ALKEM LABS LTD |
| 211856 |
002 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
2021/10/19
|
ALKEM LABS LTD |
| 209109 |
001 |
ANDA |
CHOLESTYRAMINE LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
2024/10/31
|
MACLEODS PHARMS LTD |
| 207294 |
002 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/SCOOPFUL |
Prescription |
No |
No |
AB |
2024/11/21
|
MACLEODS PHARMS LTD |
活性成分:CHOLESTYRAMINE 剂型/给药途径:POWDER;ORAL 规格:EQ 4GM RESIN/PACKET 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 |
|---|
| 073263 |
001 |
ANDA |
PREVALITE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
No |
AB |
1996/02/22
|
UPSHER SMITH LABS |
| 074557 |
001 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
Yes |
AB |
1996/08/15
|
EPIC PHARMA LLC |
| 074558 |
001 |
ANDA |
CHOLESTYRAMINE LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
Yes |
AB |
1996/08/15
|
EPIC PHARMA LLC |
| 074561 |
001 |
ANDA |
LOCHOLEST |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
No |
AB |
1996/08/15
|
CHARTWELL RX |
| 074562 |
001 |
ANDA |
LOCHOLEST LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
No |
AB |
1996/08/15
|
CHARTWELL RX |
| 074554 |
001 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Discontinued |
No |
No |
AB |
1996/10/02
|
ANI PHARMS |
| 077203 |
001 |
ANDA |
CHOLESTYRAMINE LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
No |
AB |
2005/08/26
|
ENDO OPERATIONS |
| 077204 |
001 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
No |
AB |
2005/08/26
|
ENDO OPERATIONS |
| 211119 |
001 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
No |
AB |
2020/04/06
|
AJANTA PHARMA LTD |
| 209599 |
001 |
ANDA |
CHOLESTYRAMINE LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
No |
AB |
2020/11/12
|
TAGI |
| 209597 |
001 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
No |
AB |
2021/03/09
|
TAGI |
| 211799 |
001 |
ANDA |
CHOLESTYRAMINE LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
No |
AB |
2021/10/19
|
ALKEM LABS LTD |
| 211856 |
001 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
No |
AB |
2021/10/19
|
ALKEM LABS LTD |
| 209109 |
002 |
ANDA |
CHOLESTYRAMINE LIGHT |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
No |
AB |
2024/10/31
|
MACLEODS PHARMS LTD |
| 207294 |
001 |
ANDA |
CHOLESTYRAMINE |
CHOLESTYRAMINE |
POWDER;ORAL |
EQ 4GM RESIN/PACKET |
Prescription |
No |
No |
AB |
2024/11/21
|
MACLEODS PHARMS LTD |