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 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/03/01 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 2010/04/06 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2007/07/30 |
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:BENZONATATE 剂型/给药途径:CAPSULE;ORAL 规格:100MG 治疗等效代码:AA
| 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 |
|---|
| 011210 |
001 |
NDA |
TESSALON |
BENZONATATE |
CAPSULE;ORAL |
100MG |
Prescription |
Yes |
No |
AA |
Approved Prior to Jan 1, 1982
|
PFIZER |
| 081297 |
001 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AA |
1993/01/29
|
BIONPHARMA |
| 040627 |
001 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AA |
2007/03/30
|
THEPHARMANETWORK LLC |
| 040597 |
001 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AA |
2007/06/08
|
ZYDUS PHARMS USA |
| 040682 |
001 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AA |
2007/07/30
|
HERITAGE PHARMS LABS |
| 091310 |
001 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
100MG |
Discontinued |
No |
No |
AA |
2015/01/16
|
ACELLA |
| 091133 |
001 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AA |
2015/07/30
|
STRIDES SOFTGELS |
| 202765 |
002 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AA |
2017/08/25
|
CSPC-NBP PHARM |
| 206948 |
001 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
Yes |
AA |
2018/12/19
|
PURACAP PHARM LLC |
| 211518 |
001 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AA |
2019/02/22
|
ASCENT PHARMS INC |
活性成分:BENZONATATE 剂型/给药途径:CAPSULE;ORAL 规格:200MG 治疗等效代码:AA
| 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 |
|---|
| 040749 |
001 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
Yes |
AA |
--
|
THEPHARMANETWORK LLC |
| 040597 |
002 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AA |
2007/06/08
|
ZYDUS PHARMS USA |
| 040627 |
002 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AA |
2007/07/25
|
THEPHARMANETWORK LLC |
| 040682 |
002 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AA |
2007/07/30
|
HERITAGE PHARMS LABS |
| 081297 |
002 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AA |
2007/10/30
|
BIONPHARMA |
| 091310 |
002 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
200MG |
Discontinued |
No |
No |
AA |
2015/01/16
|
ACELLA |
| 091133 |
002 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AA |
2015/07/30
|
STRIDES SOFTGELS |
| 202765 |
001 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AA |
2015/07/31
|
CSPC-NBP PHARM |
| 206948 |
002 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
Yes |
AA |
2018/12/19
|
PURACAP PHARM LLC |
| 211518 |
003 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AA |
2019/02/22
|
ASCENT PHARMS INC |