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 |
|---|
| 2024/03/21 |
SUPPL-22（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/12/13 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/06/25 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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:NYSTATIN 剂型/给药途径:SUSPENSION;ORAL 规格:100,000 UNITS/ML 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 |
|---|
| 062517 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Prescription |
No |
No |
AA |
1984/06/07
|
FOUGERA PHARMS INC |
| 062512 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Prescription |
No |
No |
AA |
1984/10/29
|
WOCKHARDT BIO AG |
| 062876 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Prescription |
No |
No |
AA |
1988/02/29
|
TARO |
| 062832 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Discontinued |
No |
No |
AA |
1991/12/27
|
MLV |
| 064042 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Discontinued |
No |
No |
AA |
1994/02/28
|
PAI HOLDINGS |
| 064142 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Discontinued |
No |
No |
AA |
1998/06/25
|
VISTAPHARM |
| 065148 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Prescription |
No |
No |
AA |
2005/06/28
|
GENUS |
| 064142 |
002 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Discontinued |
No |
No |
AA |
2011/03/07
|
VISTAPHARM |
| 203621 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Prescription |
No |
No |
AA |
2016/01/07
|
PHARM ASSOC |
| 214346 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Prescription |
No |
Yes |
AA |
2022/03/10
|
MEDLEY PHARMS |
活性成分:NYSTATIN 剂型/给药途径:SUSPENSION;ORAL 规格:100,000 UNITS/ML 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 |
|---|
| 062517 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Prescription |
No |
No |
AA |
1984/06/07
|
FOUGERA PHARMS INC |
| 062512 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Prescription |
No |
No |
AA |
1984/10/29
|
WOCKHARDT BIO AG |
| 062876 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Prescription |
No |
No |
AA |
1988/02/29
|
TARO |
| 062832 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Discontinued |
No |
No |
AA |
1991/12/27
|
MLV |
| 064042 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Discontinued |
No |
No |
AA |
1994/02/28
|
PAI HOLDINGS |
| 064142 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Discontinued |
No |
No |
AA |
1998/06/25
|
VISTAPHARM |
| 065148 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Prescription |
No |
No |
AA |
2005/06/28
|
GENUS |
| 064142 |
002 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Discontinued |
No |
No |
AA |
2011/03/07
|
VISTAPHARM |
| 203621 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Prescription |
No |
No |
AA |
2016/01/07
|
PHARM ASSOC |
| 214346 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
SUSPENSION;ORAL |
100,000 UNITS/ML |
Prescription |
No |
Yes |
AA |
2022/03/10
|
MEDLEY PHARMS |
