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 |
|---|
| 2022/04/05 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/03/25 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/06/13 |
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:SEVELAMER CARBONATE 剂型/给药途径:FOR SUSPENSION;ORAL 规格:800MG/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 |
|---|
| 022318 |
001 |
NDA |
RENVELA |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
800MG/PACKET |
Prescription |
Yes |
No |
AB |
2009/08/12
|
GENZYME |
| 207624 |
001 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
800MG/PACKET |
Prescription |
No |
No |
AB |
2017/06/13
|
AUROBINDO PHARMA |
| 210464 |
001 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
800MG/PACKET |
Prescription |
No |
No |
AB |
2018/10/25
|
DR REDDYS |
| 211316 |
001 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
800MG/PACKET |
Prescription |
No |
No |
AB |
2020/11/20
|
IMPAX |
| 209374 |
001 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
800MG/PACKET |
Prescription |
No |
No |
AB |
2021/05/17
|
BIONPHARMA |
| 201513 |
001 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
800MG/PACKET |
Discontinued |
No |
No |
AB |
2021/12/23
|
LUPIN LTD |
| 217319 |
001 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
800MG/PACKET |
Prescription |
No |
No |
AB |
2023/03/02
|
CHARTWELL RX |
| 211917 |
001 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
800MG/PACKET |
Prescription |
No |
No |
AB |
2023/09/08
|
STRIDES PHARMA |
| 207291 |
001 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
800MG/PACKET |
Prescription |
No |
No |
AB |
2024/04/25
|
MACLEODS PHARMS LTD |
| 206234 |
001 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
800MG/PACKET |
Prescription |
No |
No |
AB |
2024/07/12
|
INVAGEN PHARMS |
活性成分:SEVELAMER CARBONATE 剂型/给药途径:FOR SUSPENSION;ORAL 规格:2.4GM/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 |
|---|
| 022318 |
002 |
NDA |
RENVELA |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
2.4GM/PACKET |
Prescription |
Yes |
Yes |
AB |
2009/02/18
|
GENZYME |
| 207624 |
002 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
2.4GM/PACKET |
Prescription |
No |
No |
AB |
2017/06/13
|
AUROBINDO PHARMA |
| 210464 |
002 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
2.4GM/PACKET |
Prescription |
No |
No |
AB |
2018/10/25
|
DR REDDYS |
| 211316 |
002 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
2.4GM/PACKET |
Prescription |
No |
No |
AB |
2020/11/20
|
IMPAX |
| 201513 |
002 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
2.4GM/PACKET |
Discontinued |
No |
No |
AB |
2021/12/23
|
LUPIN LTD |
| 217319 |
002 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
2.4GM/PACKET |
Prescription |
No |
No |
AB |
2023/03/02
|
CHARTWELL RX |
| 211917 |
002 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
2.4GM/PACKET |
Prescription |
No |
No |
AB |
2023/09/08
|
STRIDES PHARMA |
| 207291 |
002 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
2.4GM/PACKET |
Prescription |
No |
No |
AB |
2024/04/25
|
MACLEODS PHARMS LTD |
| 206234 |
002 |
ANDA |
SEVELAMER CARBONATE |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
2.4GM/PACKET |
Prescription |
No |
No |
AB |
2024/07/12
|
INVAGEN PHARMS |
