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 |
|---|
| 2023/12/15 |
SUPPL-46（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/09/27 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2018/06/28 |
SUPPL-39（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/01/13 |
SUPPL-38（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2009/01/26 |
SUPPL-37（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/01/16 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2001/06/15 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/07/10 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/04/23 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1992/04/22 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/12/23 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/11/08 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/07/26 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 1988/07/26 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/07/26 |
SUPPL-13（补充） |
Approval |
Efficacy |
|
|
|
| 1943/03/23 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
STANDARD
|
|
|
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:HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 剂型/给药途径:TABLET;ORAL 规格:1.5MG;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 |
|---|
| 005213 |
001 |
NDA |
HYCODAN |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
TABLET;ORAL |
1.5MG;5MG |
Prescription |
Yes |
No |
AA |
1988/07/26
|
GENUS |
| 091528 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
TABLET;ORAL |
1.5MG;5MG |
Discontinued |
No |
No |
AA |
2011/04/20
|
NOVEL LABS INC |
| 207176 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
TABLET;ORAL |
1.5MG;5MG |
Prescription |
No |
Yes |
AA |
2017/08/07
|
AVANTHI INC |
活性成分:HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 剂型/给药途径:SYRUP;ORAL 规格:1.5MG/5ML;5MG/5ML 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 |
|---|
| 088008 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
Prescription |
No |
No |
AA |
1983/03/03
|
WOCKHARDT BIO AG |
| 088017 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
Prescription |
No |
No |
AA |
1983/07/05
|
ACTAVIS MID ATLANTIC |
| 005213 |
002 |
NDA |
HYCODAN |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
Prescription |
Yes |
No |
AA |
1988/07/26
|
GENUS |
| 040613 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
Discontinued |
No |
No |
AA |
2008/02/08
|
PAI HOLDINGS PHARM |
| 203535 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
Prescription |
No |
No |
AA |
2017/02/13
|
NOVEL LABS INC |
| 205731 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
Prescription |
No |
No |
AA |
2017/02/15
|
PADAGIS US |
| 207487 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
Prescription |
No |
Yes |
AA |
2017/02/21
|
ABHAI LLC |
