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 |
|---|
| 2023/03/21 |
ORIG-1（原始申请） |
Approval |
|
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:NITROFURANTOIN, MACROCRYSTALLINE 剂型/给药途径:CAPSULE;ORAL 规格:25MG 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 |
|---|
| 016620 |
003 |
NDA |
MACRODANTIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
25MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
ALMATICA |
| 091095 |
001 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
25MG |
Discontinued |
No |
No |
AB |
2015/06/18
|
ACTAVIS LABS FL INC |
| 201722 |
001 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2016/02/16
|
SUN PHARM INDUSTRIES |
| 211935 |
001 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2021/06/25
|
ALEMBIC |
| 217272 |
001 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2023/03/21
|
MANKIND PHARMA |
| 077025 |
002 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2024/10/02
|
AUROBINDO PHARMA USA |
活性成分:NITROFURANTOIN, MACROCRYSTALLINE 剂型/给药途径:CAPSULE;ORAL 规格:50MG 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 |
|---|
| 016620 |
001 |
NDA |
MACRODANTIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
50MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
ALMATICA |
| 073671 |
001 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
1993/01/28
|
IMPAX LABS INC |
| 074967 |
001 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
1997/07/09
|
AUROBINDO PHARMA USA |
| 091095 |
002 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
50MG |
Discontinued |
No |
No |
AB |
2015/06/18
|
ACTAVIS LABS FL INC |
| 201722 |
002 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2016/02/16
|
SUN PHARM INDUSTRIES |
| 205005 |
001 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2017/12/12
|
ZYDUS PHARMS |
| 203233 |
001 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2018/07/09
|
NOVEL LABS INC |
| 211935 |
002 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2021/06/25
|
ALEMBIC |
| 217272 |
002 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/03/21
|
MANKIND PHARMA |
活性成分:NITROFURANTOIN, MACROCRYSTALLINE 剂型/给药途径:CAPSULE;ORAL 规格:100MG 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 |
|---|
| 016620 |
002 |
NDA |
MACRODANTIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
100MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
ALMATICA |
| 073652 |
001 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
1993/01/28
|
IMPAX LABS INC |
| 074967 |
002 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
1997/07/09
|
AUROBINDO PHARMA USA |
| 077025 |
001 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2004/08/18
|
AUROBINDO PHARMA USA |
| 091095 |
003 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
100MG |
Discontinued |
No |
No |
AB |
2015/06/18
|
ACTAVIS LABS FL INC |
| 201722 |
003 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2016/02/16
|
SUN PHARM INDUSTRIES |
| 205005 |
002 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2017/12/12
|
ZYDUS PHARMS |
| 203233 |
002 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2018/07/09
|
NOVEL LABS INC |
| 211935 |
003 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/06/25
|
ALEMBIC |
| 217272 |
003 |
ANDA |
NITROFURANTOIN |
NITROFURANTOIN, MACROCRYSTALLINE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2023/03/21
|
MANKIND PHARMA |