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 |
|---|
| 2013/12/19 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
STANDARD
;Orphan
|
|
|
>>>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 |
|---|
| 2024/08/26 |
SUPPL-8（补充） |
Approval |
Labeling-Package Insert |
STANDARD
;Orphan
|
|
|
| 2020/03/16 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
;Orphan
|
|
|
| 2019/12/13 |
SUPPL-7（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert |
STANDARD
;Orphan
|
|
|
| 2019/05/02 |
SUPPL-5（补充） |
Approval |
Labeling-Patient Package Insert,Labeling-Package Insert |
STANDARD
;Orphan
|
|
|
| 2016/08/09 |
SUPPL-2（补充） |
Approval |
Labeling-Package Insert |
STANDARD
;Orphan
|
|
|
| 2015/10/28 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
;Orphan
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
与本品治疗等效的药品
>>>活性成分:SAPROPTERIN DIHYDROCHLORIDE; 剂型/给药途径:POWDER;ORAL; 规格:100MG/PACKET; 治疗等效代码:AB<<<
| 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 |
|---|
| 205065 |
001 |
NDA |
KUVAN |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER;ORAL |
100MG/PACKET |
Prescription |
Yes |
Yes |
AB |
2013/12/19
|
BIOMARIN PHARM |
| 207207 |
001 |
ANDA |
SAPROPTERIN DIHYDROCHLORIDE |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER;ORAL |
100MG/PACKET |
Prescription |
No |
No |
AB |
2019/08/20
|
PH HEALTH |
| 209452 |
001 |
ANDA |
SAPROPTERIN DIHYDROCHLORIDE |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER;ORAL |
100MG/PACKET |
Prescription |
No |
No |
AB |
2021/03/30
|
DR REDDYS |
| 215420 |
001 |
ANDA |
SAPROPTERIN DIHYDROCHLORIDE |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER;ORAL |
100MG/PACKET |
Prescription |
No |
No |
AB |
2022/08/18
|
ANNORA PHARMA |
| 218645 |
001 |
ANDA |
ZELVYSIA |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER;ORAL |
100MG/PACKET |
Prescription |
No |
No |
AB |
2025/04/29
|
AUCTA |
| 216432 |
001 |
ANDA |
SAPROPTERIN DIHYDROCHLORIDE |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER;ORAL |
100MG/PACKET |
Prescription |
No |
No |
AB |
2025/09/03
|
HOPEWELL PHARMA |
>>>活性成分:SAPROPTERIN DIHYDROCHLORIDE; 剂型/给药途径:POWDER;ORAL; 规格:500MG/PACKET; 治疗等效代码:AB<<<
| 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 |
|---|
| 205065 |
002 |
NDA |
KUVAN |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER;ORAL |
500MG/PACKET |
Prescription |
Yes |
No |
AB |
2015/10/27
|
BIOMARIN PHARM |
| 210027 |
001 |
ANDA |
SAPROPTERIN DIHYDROCHLORIDE |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AB |
2019/08/20
|
PH HEALTH |
| 215798 |
001 |
ANDA |
SAPROPTERIN DIHYDROCHLORIDE |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AB |
2022/05/13
|
DR REDDYS |
| 215420 |
002 |
ANDA |
SAPROPTERIN DIHYDROCHLORIDE |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AB |
2022/08/18
|
ANNORA PHARMA |
| 218645 |
002 |
ANDA |
ZELVYSIA |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AB |
2025/04/29
|
AUCTA |
| 216432 |
002 |
ANDA |
SAPROPTERIN DIHYDROCHLORIDE |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER;ORAL |
500MG/PACKET |
Prescription |
No |
No |
AB |
2025/09/03
|
HOPEWELL PHARMA |
