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 |
2013/04/30 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/12/28 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/11/30 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
2002/12/12 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/12/22 |
SUPPL-1(补充) |
Approval |
Labeling |
|
|
|
1999/09/07 |
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:DICYCLOMINE 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 |
084285 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
CAPSULE;ORAL |
10MG |
Prescription |
No |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
LANNETT |
085082 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
1986/06/19
|
WATSON LABS |
040204 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
1997/02/28
|
WEST WARD |
040319 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
1999/09/07
|
AUROBINDO PHARMA USA |
217054 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2022/12/27
|
TWI PHARMS |
216639 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2023/03/24
|
COREPHARMA |
217531 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2023/08/30
|
PRINSTON INC |
218018 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2024/07/01
|
ANNORA PHARMA |