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 |
|---|
| 2002/10/03 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/10/15 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/05/30 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/11/15 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/01/24 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/06/01 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/08/26 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/07/05 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/07/05 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1994/07/05 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/06/13 |
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:CREAM;TOPICAL 规格:100,000 UNITS/GM 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 |
|---|
| 061966 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
CREAM;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
COSETTE |
| 062129 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
CREAM;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
FOUGERA PHARMS |
| 062225 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
CREAM;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
PADAGIS US |
| 062949 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
CREAM;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
1988/06/13
|
ACTAVIS MID ATLANTIC |
| 064022 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
CREAM;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
Yes |
AT |
1993/01/29
|
TARO |
| 207733 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
CREAM;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
2017/09/26
|
CROWN LABS INC |
| 212557 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
CREAM;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
2019/07/24
|
TORRENT |
| 213566 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
CREAM;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
2021/08/10
|
MACLEODS PHARMS LTD |