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 |
2013/11/27 |
SUPPL-44(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/08/13 |
SUPPL-43(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/12/31 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/03/25 |
SUPPL-39(补充) |
Approval |
Labeling |
|
|
|
1997/07/16 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/07/16 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/01/19 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/01/19 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/01/19 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/05/26 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/07/11 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/03/12 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
1990/08/23 |
SUPPL-26(补充) |
Approval |
Labeling |
|
|
|
1990/03/15 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
1989/03/31 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/03/31 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/15 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/07/30 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/03/04 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/12/06 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/12/06 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/05/13 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1979/09/26 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/08/17 |
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:TABLET;ORAL 规格:20MG 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 |
085223 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
Yes |
AB |
1986/07/30
|
WATSON LABS |
040161 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
1996/10/01
|
HIKMA PHARMS |
040230 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
1999/02/26
|
LANNETT |
040317 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
1999/09/07
|
AUROBINDO PHARMA USA |
216760 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2022/11/28
|
COREPHARMA |
216736 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2022/12/14
|
RUBICON |
216782 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/06/01
|
TWI PHARMS |
217916 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/08/04
|
BIONPHARMA |
217566 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2024/05/07
|
ANNORA PHARMA |