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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 1980/12/12 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2021/05/14 |
SUPPL-31（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2020/04/24 |
SUPPL-30（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2012/12/18 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2012/12/14 |
SUPPL-24（补充） |
Approval |
Labeling-Container/Carton Labels,Labeling-Package Insert |
STANDARD
|
|
|
| 2003/07/22 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/12/04 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2002/05/02 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2000/02/18 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/08/17 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1999/03/11 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1999/02/05 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/12/18 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/08/04 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1998/01/15 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/06/25 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/03/05 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1995/11/01 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1995/11/01 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1995/06/13 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1994/07/27 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1994/06/13 |
SUPPL-2（补充） |
Approval |
Labeling |
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:TOBRAMYCIN; 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC; 规格:0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 治疗等效代码:AT<<<
| 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 |
|---|
| 050541 |
001 |
NDA |
TOBREX |
TOBRAMYCIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AT |
Approved Prior to Jan 1, 1982
|
NOVARTIS |
