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 |
|---|
| 2022/01/21 |
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:COLESEVELAM HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:625MG 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 |
|---|
| 021176 |
001 |
NDA |
WELCHOL |
COLESEVELAM HYDROCHLORIDE |
TABLET;ORAL |
625MG |
Prescription |
Yes |
Yes |
AB |
2000/05/26
|
COSETTE |
| 091600 |
001 |
ANDA |
COLESEVELAM HYDROCHLORIDE |
COLESEVELAM HYDROCHLORIDE |
TABLET;ORAL |
625MG |
Prescription |
No |
No |
AB |
2018/05/16
|
IMPAX LABS INC |
| 203480 |
001 |
ANDA |
COLESEVELAM HYDROCHLORIDE |
COLESEVELAM HYDROCHLORIDE |
TABLET;ORAL |
625MG |
Prescription |
No |
No |
AB |
2018/05/18
|
GLENMARK PHARMS LTD |
| 209038 |
001 |
ANDA |
COLESEVELAM HYDROCHLORIDE |
COLESEVELAM HYDROCHLORIDE |
TABLET;ORAL |
625MG |
Prescription |
No |
No |
AB |
2018/10/05
|
ALKEM LABS LTD |
| 210889 |
001 |
ANDA |
COLESEVELAM HYDROCHLORIDE |
COLESEVELAM HYDROCHLORIDE |
TABLET;ORAL |
625MG |
Prescription |
No |
No |
AB |
2018/10/05
|
DR REDDYS |
| 208670 |
001 |
ANDA |
COLESEVELAM HYDROCHLORIDE |
COLESEVELAM HYDROCHLORIDE |
TABLET;ORAL |
625MG |
Prescription |
No |
No |
AB |
2019/09/13
|
BIONPHARMA |
| 207765 |
001 |
ANDA |
COLESEVELAM HYDROCHLORIDE |
COLESEVELAM HYDROCHLORIDE |
TABLET;ORAL |
625MG |
Prescription |
No |
No |
AB |
2019/10/07
|
ZYDUS PHARMS |
| 209946 |
001 |
ANDA |
COLESEVELAM HYDROCHLORIDE |
COLESEVELAM HYDROCHLORIDE |
TABLET;ORAL |
625MG |
Prescription |
No |
No |
AB |
2020/07/15
|
ZHEJIANG JINGXIN |
| 212050 |
001 |
ANDA |
COLESEVELAM HYDROCHLORIDE |
COLESEVELAM HYDROCHLORIDE |
TABLET;ORAL |
625MG |
Prescription |
No |
No |
AB |
2020/12/04
|
INVENTIA |
| 206036 |
001 |
ANDA |
COLESEVELAM HYDROCHLORIDE |
COLESEVELAM HYDROCHLORIDE |
TABLET;ORAL |
625MG |
Prescription |
No |
No |
AB |
2021/10/14
|
BEIJING TIDE PHARM |
| 213456 |
001 |
ANDA |
COLESEVELAM HYDROCHLORIDE |
COLESEVELAM HYDROCHLORIDE |
TABLET;ORAL |
625MG |
Discontinued |
No |
No |
AB |
2022/01/21
|
UNITED RES LABS |