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 |
|---|
| 2019/11/25 |
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:PILOCARPINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;OPHTHALMIC 规格:1% 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 |
|---|
| 200890 |
001 |
NDA |
ISOPTO CARPINE |
PILOCARPINE HYDROCHLORIDE |
SOLUTION;OPHTHALMIC |
1% |
Prescription |
Yes |
Yes |
AT |
2010/06/22
|
SANDOZ |
| 204398 |
001 |
ANDA |
PILOCARPINE HYDROCHLORIDE |
PILOCARPINE HYDROCHLORIDE |
SOLUTION;OPHTHALMIC |
1% |
Prescription |
No |
No |
AT |
2017/09/27
|
RISING |
| 210384 |
001 |
ANDA |
PILOCARPINE HYDROCHLORIDE |
PILOCARPINE HYDROCHLORIDE |
SOLUTION;OPHTHALMIC |
1% |
Prescription |
No |
No |
AT |
2019/11/25
|
SOMERSET THERAPS LLC |
| 214193 |
001 |
ANDA |
PILOCARPINE HYDROCHLORIDE |
PILOCARPINE HYDROCHLORIDE |
SOLUTION;OPHTHALMIC |
1% |
Prescription |
No |
No |
AT |
2020/09/21
|
AMNEAL |
活性成分:PILOCARPINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;OPHTHALMIC 规格:2% 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 |
|---|
| 200890 |
002 |
NDA |
ISOPTO CARPINE |
PILOCARPINE HYDROCHLORIDE |
SOLUTION;OPHTHALMIC |
2% |
Prescription |
Yes |
Yes |
AT |
2010/06/22
|
SANDOZ |
| 204398 |
002 |
ANDA |
PILOCARPINE HYDROCHLORIDE |
PILOCARPINE HYDROCHLORIDE |
SOLUTION;OPHTHALMIC |
2% |
Prescription |
No |
No |
AT |
2017/09/27
|
RISING |
| 210384 |
002 |
ANDA |
PILOCARPINE HYDROCHLORIDE |
PILOCARPINE HYDROCHLORIDE |
SOLUTION;OPHTHALMIC |
2% |
Prescription |
No |
No |
AT |
2019/11/25
|
SOMERSET THERAPS LLC |
| 214193 |
002 |
ANDA |
PILOCARPINE HYDROCHLORIDE |
PILOCARPINE HYDROCHLORIDE |
SOLUTION;OPHTHALMIC |
2% |
Prescription |
No |
No |
AT |
2020/09/21
|
AMNEAL |
活性成分:PILOCARPINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;OPHTHALMIC 规格:4% 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 |
|---|
| 200890 |
003 |
NDA |
ISOPTO CARPINE |
PILOCARPINE HYDROCHLORIDE |
SOLUTION;OPHTHALMIC |
4% |
Prescription |
Yes |
Yes |
AT |
2010/06/22
|
SANDOZ |
| 204398 |
003 |
ANDA |
PILOCARPINE HYDROCHLORIDE |
PILOCARPINE HYDROCHLORIDE |
SOLUTION;OPHTHALMIC |
4% |
Prescription |
No |
No |
AT |
2017/09/27
|
RISING |
| 210384 |
003 |
ANDA |
PILOCARPINE HYDROCHLORIDE |
PILOCARPINE HYDROCHLORIDE |
SOLUTION;OPHTHALMIC |
4% |
Prescription |
No |
No |
AT |
2019/11/25
|
SOMERSET THERAPS LLC |
| 214193 |
003 |
ANDA |
PILOCARPINE HYDROCHLORIDE |
PILOCARPINE HYDROCHLORIDE |
SOLUTION;OPHTHALMIC |
4% |
Prescription |
No |
No |
AT |
2020/09/21
|
AMNEAL |