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 |
|---|
| 2017/10/30 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2011/08/01 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 2009/03/25 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 2008/05/29 |
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:AMANTADINE HYDROCHLORIDE 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 |
|---|
| 070589 |
001 |
ANDA |
AMANTADINE HYDROCHLORIDE |
AMANTADINE HYDROCHLORIDE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
1986/08/05
|
UPSHER SMITH LABS |
| 071293 |
001 |
ANDA |
AMANTADINE HYDROCHLORIDE |
AMANTADINE HYDROCHLORIDE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
1987/02/18
|
SANDOZ |
| 078720 |
001 |
ANDA |
AMANTADINE HYDROCHLORIDE |
AMANTADINE HYDROCHLORIDE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
Yes |
AB |
2008/05/29
|
BIONPHARMA |
| 208278 |
001 |
ANDA |
AMANTADINE HYDROCHLORIDE |
AMANTADINE HYDROCHLORIDE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2016/05/31
|
ZYDUS PHARMS |
| 208107 |
001 |
ANDA |
AMANTADINE HYDROCHLORIDE |
AMANTADINE HYDROCHLORIDE |
CAPSULE;ORAL |
100MG |
Discontinued |
No |
No |
AB |
2016/12/06
|
WATSON LABS INC |
| 209047 |
001 |
ANDA |
AMANTADINE HYDROCHLORIDE |
AMANTADINE HYDROCHLORIDE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2017/06/07
|
STRIDES PHARMA |
| 209171 |
001 |
ANDA |
AMANTADINE HYDROCHLORIDE |
AMANTADINE HYDROCHLORIDE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2017/06/12
|
HERITAGE PHARMA |
| 208966 |
001 |
ANDA |
AMANTADINE HYDROCHLORIDE |
AMANTADINE HYDROCHLORIDE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2017/06/21
|
ALEMBIC |
| 210129 |
001 |
ANDA |
AMANTADINE HYDROCHLORIDE |
AMANTADINE HYDROCHLORIDE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2020/03/02
|
RISING |
| 212044 |
001 |
ANDA |
AMANTADINE HYDROCHLORIDE |
AMANTADINE HYDROCHLORIDE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2020/05/21
|
RUBICON |
| 211354 |
001 |
ANDA |
AMANTADINE HYDROCHLORIDE |
AMANTADINE HYDROCHLORIDE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/02/18
|
STRIDES SOFTGELS |
| 214580 |
001 |
ANDA |
AMANTADINE HYDROCHLORIDE |
AMANTADINE HYDROCHLORIDE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/12/20
|
HUMANWELL PURACAP |