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 |
|---|
| 2020/11/27 |
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:CHLORTHALIDONE 剂型/给药途径:TABLET;ORAL 规格:25MG 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 |
|---|
| 086831 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
MYLAN |
| 089286 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
1986/07/21
|
SUN PHARM INDUSTRIES |
| 206904 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2017/03/30
|
NOVAST LABS |
| 207222 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2018/05/24
|
UMEDICA |
| 210742 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2018/10/12
|
APPCO |
| 211063 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2019/02/26
|
CHARTWELL RX |
| 207813 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2019/05/10
|
ZYDUS PHARMS |
| 207204 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2019/07/01
|
AMNEAL PHARMS CO |
| 211627 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2019/08/06
|
UNICHEM |
| 213412 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2020/02/11
|
ALKEM LABS LTD |
| 214129 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2020/11/27
|
AJANTA PHARMA LTD |
| 209068 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Discontinued |
No |
No |
AB |
2022/01/25
|
SUNNY |
| 211320 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2022/02/09
|
INVENTIA |
| 212878 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2022/02/24
|
PHARMOBEDIENT |
| 215587 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2022/08/04
|
MANKIND PHARMA |
| 216262 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2022/08/26
|
ALEMBIC |
| 209162 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2024/11/12
|
IPCA LABS LTD |
活性成分:CHLORTHALIDONE 剂型/给药途径:TABLET;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 |
|---|
| 086831 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
MYLAN |
| 089286 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1986/07/21
|
SUN PHARM INDUSTRIES |
| 206904 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2017/03/30
|
NOVAST LABS |
| 207222 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2018/05/24
|
UMEDICA |
| 210742 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2018/10/12
|
APPCO |
| 211063 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2019/02/26
|
CHARTWELL RX |
| 207813 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2019/05/10
|
ZYDUS PHARMS |
| 207204 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2019/07/01
|
AMNEAL PHARMS CO |
| 211627 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2019/08/06
|
UNICHEM |
| 213412 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2020/02/11
|
ALKEM LABS LTD |
| 214129 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2020/11/27
|
AJANTA PHARMA LTD |
| 209068 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Discontinued |
No |
No |
AB |
2022/01/25
|
SUNNY |
| 211320 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2022/02/09
|
INVENTIA |
| 212875 |
001 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2022/02/24
|
PHARMOBEDIENT |
| 215587 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2022/08/04
|
MANKIND PHARMA |
| 216262 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2022/08/26
|
ALEMBIC |
| 209162 |
002 |
ANDA |
CHLORTHALIDONE |
CHLORTHALIDONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2024/11/12
|
IPCA LABS LTD |