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 |
|---|
| 2019/03/04 |
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 |
|---|
| 2024/03/21 |
SUPPL-18（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2024/03/21 |
SUPPL-13（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2024/03/21 |
SUPPL-11（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2024/03/21 |
SUPPL-5（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2024/03/21 |
SUPPL-2（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels,Labeling-Patient Package Insert |
STANDARD
|
|
|
| 2024/03/21 |
SUPPL-1（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:FULVESTRANT; 剂型/给药途径:SOLUTION;INTRAMUSCULAR; 规格:250MG/5ML (50MG/ML); 治疗等效代码:AO<<<
| 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 |
|---|
| 021344 |
001 |
NDA |
FASLODEX |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
Yes |
Yes |
AO |
2002/04/25
|
ASTRAZENECA |
| 210044 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2019/03/04
|
AMNEAL |
| 205935 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2019/05/14
|
SANDOZ |
| 210326 |
001 |
NDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2019/05/20
|
FRESENIUS KABI USA |
| 208811 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Discontinued |
No |
No |
AO |
2019/07/23
|
EUGIA PHARMA |
| 207754 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2019/08/22
|
GLENMARK PHARMS INC |
| 205871 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2019/08/22
|
SAGENT PHARMS INC |
| 209714 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2019/11/21
|
HBT LABS INC |
| 211422 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2020/02/07
|
CHIA TAI TIANQING |
| 209246 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2020/08/07
|
DR REDDYS |
| 211689 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2020/11/17
|
ACCORD HLTHCARE |
| 215234 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2021/07/29
|
ZYDUS PHARMS |
| 213553 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2021/08/13
|
XIROMED |
| 214682 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2022/02/10
|
JIANGSU HANSOH PHARM |
| 215077 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2022/12/22
|
ALEMBIC |
| 215169 |
001 |
ANDA |
FULVESTRANT |
FULVESTRANT |
SOLUTION;INTRAMUSCULAR |
250MG/5ML (50MG/ML) |
Prescription |
No |
No |
AO |
2023/06/30
|
EUGIA PHARMA |
