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 |
2023/01/17 |
SUPPL-95(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/02/05 |
SUPPL-93(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/12/16 |
SUPPL-89(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/12/04 |
SUPPL-85(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/06/23 |
SUPPL-84(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/06/23 |
SUPPL-83(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/12/21 |
SUPPL-81(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/05/20 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/05/13 |
SUPPL-80(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/12/01 |
SUPPL-77(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/11/16 |
SUPPL-78(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/04/16 |
SUPPL-76(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/12/23 |
SUPPL-75(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/08/02 |
SUPPL-74(补充) |
Approval |
Labeling |
|
|
|
1992/05/01 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/04/03 |
SUPPL-73(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/04/03 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/05/10 |
SUPPL-69(补充) |
Approval |
Labeling |
|
|
|
1987/07/17 |
SUPPL-67(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/07/17 |
SUPPL-66(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/03/20 |
SUPPL-65(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/11/12 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/11/12 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/11/12 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/11/12 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/07 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/06/10 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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 剂型/给药途径:CAPSULE;ORAL 规格: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 |
084678 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
CAPSULE;ORAL |
5MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
CHARTWELL RX |
084768 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
CAPSULE;ORAL |
5MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
BARR |
085461 |
001 |
ANDA |
LIBRIUM |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
CAPSULE;ORAL |
5MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
VALEANT PHARM INTL |