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 |
|---|
| 2019/11/15 |
ORIG-1（原始申请） |
Approval |
|
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 |
|---|
| 2023/09/19 |
SUPPL-7（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2023/09/19 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2023/09/19 |
SUPPL-5（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2023/09/19 |
SUPPL-3（补充） |
Approval |
Labeling-Package Insert |
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:DAPTOMYCIN; 剂型/给药途径:POWDER;INTRAVENOUS; 规格:500MG/VIAL; 治疗等效代码:AP<<<
| 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 |
|---|
| 091039 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2016/03/25
|
TEVA PHARMS USA |
| 206005 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2016/06/15
|
XELLIA PHARMS APS |
| 206077 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2018/04/11
|
FRESENIUS KABI USA |
| 205037 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2018/06/05
|
MYLAN LABS LTD |
| 208375 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2019/05/01
|
DR REDDYS |
| 211961 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2019/06/24
|
ACCORD HLTHCARE |
| 212513 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2019/06/26
|
BE PHARMS |
| 212022 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2019/08/22
|
HENGRUI PHARMA |
| 207104 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2019/11/15
|
SAGENT PHARMS INC |
| 212250 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2021/04/21
|
HISUN PHARM HANGZHOU |
| 213623 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2021/06/29
|
MEITHEAL |
| 215316 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
Yes |
AP |
2021/08/24
|
QILU PHARM HAINAN |
| 213171 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2021/09/02
|
EUGIA PHARMA |
| 215215 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Discontinued |
No |
No |
AP |
2021/11/26
|
HANGZHOU ZHONGMEI |
| 215890 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2022/08/18
|
HAINAN POLY PHARM |
| 216413 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2022/09/23
|
ASPIRO |
| 213966 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2023/08/07
|
MYLAN |
| 217215 |
001 |
ANDA |
DAPTOMYCIN |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Prescription |
No |
No |
AP |
2024/08/29
|
BIOCON PHARMA |