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 |
|---|
| 2024/08/07 |
SUPPL-21（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/08/07 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/08/07 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/12/20 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2008/02/29 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 2007/03/28 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 2002/08/26 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/10/26 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/10/26 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/10/26 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/08/14 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/08/14 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 2000/08/10 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1978/02/21 |
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:ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:0.025MG;2.5MG 治疗等效代码:AA
| 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 |
|---|
| 012462 |
001 |
NDA |
LOMOTIL |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
Prescription |
Yes |
Yes |
AA |
Approved Prior to Jan 1, 1982
|
PFIZER |
| 085372 |
001 |
ANDA |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
Prescription |
No |
No |
AA |
Approved Prior to Jan 1, 1982
|
LANNETT |
| 085762 |
001 |
ANDA |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
Discontinued |
No |
No |
AA |
Approved Prior to Jan 1, 1982
|
MYLAN |
| 086727 |
001 |
ANDA |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
Discontinued |
No |
No |
AA |
Approved Prior to Jan 1, 1982
|
ANI PHARMS |
| 210571 |
001 |
ANDA |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
Discontinued |
No |
No |
AA |
2018/08/31
|
UPSHER SMITH LABS |
| 210819 |
001 |
ANDA |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
Prescription |
No |
No |
AA |
2018/11/13
|
BAYSHORE PHARMS LLC |
| 213413 |
001 |
ANDA |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
Prescription |
No |
No |
AA |
2020/02/20
|
LEADING |
| 213335 |
001 |
ANDA |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
Prescription |
No |
No |
AA |
2020/10/06
|
SPECGX LLC |
| 207128 |
001 |
ANDA |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
Prescription |
No |
No |
AA |
2020/10/21
|
CHARTWELL RX |
| 211362 |
001 |
ANDA |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
TABLET;ORAL |
0.025MG;2.5MG |
Prescription |
No |
No |
AA |
2021/01/27
|
WINDER LABS LLC |