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 |
2001/05/30 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/01/18 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/06/01 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/10/25 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/10/25 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/06/19 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/10/11 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/05/29 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/05/09 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/11/13 |
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:OINTMENT;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 |
062124 |
002 |
ANDA |
NYSTATIN |
NYSTATIN |
OINTMENT;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
Yes |
AT |
1982/09/23
|
FOUGERA PHARMS |
062472 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
OINTMENT;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
1984/02/13
|
PADAGIS US |
062840 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
OINTMENT;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
1987/11/13
|
ACTAVIS MID ATLANTIC |
209114 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
OINTMENT;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
2017/10/06
|
COSETTE |
209082 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
OINTMENT;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
2018/05/21
|
LYNE |
207767 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
OINTMENT;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
2018/05/25
|
ZYDUS LIFESCIENCES |
211838 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
OINTMENT;TOPICAL |
100,000 UNITS/GM |
Discontinued |
No |
No |
AT |
2019/01/28
|
TORRENT |
213826 |
001 |
ANDA |
NYSTATIN |
NYSTATIN |
OINTMENT;TOPICAL |
100,000 UNITS/GM |
Prescription |
No |
No |
AT |
2021/01/14
|
MACLEODS PHARMS LTD |