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-101(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/12/16 |
SUPPL-98(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/02/03 |
SUPPL-94(补充) |
Approval |
Labeling |
|
|
|
1989/11/03 |
SUPPL-92(补充) |
Approval |
Labeling |
|
|
|
1989/05/01 |
SUPPL-91(补充) |
Approval |
Labeling |
|
|
|
1985/01/08 |
SUPPL-89(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/05/25 |
SUPPL-86(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/01/13 |
SUPPL-85(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/01/13 |
SUPPL-84(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/06/21 |
SUPPL-82(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/08/17 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/08/17 |
SUPPL-78(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/28 |
SUPPL-77(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/05/27 |
SUPPL-74(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/03/15 |
SUPPL-73(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/03/15 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/03/15 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/03/15 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/03/15 |
SUPPL-68(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/06/15 |
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:10MG 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 |
083116 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
BARR |
084041 |
001 |
ANDA |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
CHARTWELL RX |
085472 |
001 |
ANDA |
LIBRIUM |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
CAPSULE;ORAL |
10MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
VALEANT PHARM INTL |