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 |
|---|
| 2023/01/13 |
SUPPL-68（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/02/05 |
SUPPL-67（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/01/13 |
SUPPL-65（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/12/16 |
SUPPL-66（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1966/09/01 |
ORIG-1（原始申请） |
Approval |
Type 4 - New Combination |
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:CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 剂型/给药途径:CAPSULE;ORAL 规格:5MG;2.5MG 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 |
|---|
| 012750 |
001 |
NDA |
LIBRAX |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
BAUSCH |
| 211421 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Prescription |
No |
No |
AB |
2020/07/07
|
NUVO PHARMS INC |
| 210579 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Prescription |
No |
No |
AB |
2020/07/29
|
MISEMER |
| 213530 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Prescription |
No |
No |
AB |
2020/10/20
|
CHARTWELL RX |
| 214065 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Prescription |
No |
No |
AB |
2021/04/26
|
ALKEM LABS LTD |
| 214698 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Prescription |
No |
No |
AB |
2021/05/10
|
DR REDDYS |
| 215555 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Prescription |
No |
No |
AB |
2021/10/25
|
AMNEAL |
| 211476 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Discontinued |
No |
No |
AB |
2021/11/02
|
TEVA PHARMS USA |
| 215835 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Prescription |
No |
No |
AB |
2022/07/19
|
MICRO LABS |
| 215453 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Prescription |
No |
No |
AB |
2022/07/29
|
COREPHARMA |
| 216419 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Prescription |
No |
No |
AB |
2023/09/14
|
AUROBINDO PHARMA LTD |
| 216969 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Prescription |
No |
No |
AB |
2023/09/15
|
ALEMBIC |
| 217385 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
CAPSULE;ORAL |
5MG;2.5MG |
Discontinued |
No |
No |
AB |
2023/12/14
|
TORRENT |
