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 |
2011/01/20 |
SUPPL-53(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2002/07/23 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/11/01 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/06/30 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/06/25 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/06/08 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/12/01 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/09/04 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
1986/10/08 |
SUPPL-30(补充) |
Approval |
Labeling |
|
|
|
1985/11/29 |
SUPPL-29(补充) |
Approval |
Labeling |
|
|
|
1985/11/29 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
1985/11/05 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/06/13 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/07/15 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/07/03 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/08/28 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/07/06 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/10/24 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/09/29 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1978/09/29 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/03/31 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1974/12/30 |
SUPPL-11(补充) |
Approval |
Supplement |
STANDARD
|
|
|
1972/04/12 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
1958/02/10 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
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: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 |
Discontinued |
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 |
Prescription |
No |
No |
AA |
2015/01/16
|
ACELLA |
091133 |
001 |
ANDA |
BENZONATATE |
BENZONATATE |
CAPSULE;ORAL |
100MG |
Prescription |
No |
No |
AA |
2015/07/30
|
STRIDES PHARMA |
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 |