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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 1967/11/06 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2013/02/22 |
SUPPL-66（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2008/10/30 |
SUPPL-63（补充） |
Approval |
Labeling |
STANDARD
|
|
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| 2004/03/24 |
SUPPL-60（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/02/06 |
SUPPL-58（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/02/06 |
SUPPL-57（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/10/10 |
SUPPL-56（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1998/05/14 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1998/05/08 |
SUPPL-54（补充） |
Approval |
Manufacturing (CMC)-Packaging |
PRIORITY
|
|
|
| 1995/06/20 |
SUPPL-53（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1987/11/23 |
SUPPL-51（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1987/11/02 |
SUPPL-52（补充） |
Approval |
Manufacturing (CMC)-Expiration Date |
PRIORITY
|
|
|
| 1987/06/25 |
SUPPL-46（补充） |
Approval |
Labeling |
|
|
|
| 1987/05/19 |
SUPPL-50（补充） |
Approval |
Manufacturing (CMC)-Formulation |
PRIORITY
|
|
|
| 1986/01/03 |
SUPPL-49（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1985/09/12 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1982/02/24 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1981/11/03 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1981/08/18 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC)-Expiration Date |
PRIORITY
|
|
|
| 1981/08/18 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1981/07/29 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1981/01/09 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1979/04/03 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1979/04/03 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1978/12/21 |
SUPPL-36（补充） |
Approval |
Labeling |
|
|
|
| 1978/06/27 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1978/06/26 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1978/05/03 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1978/04/07 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1977/07/05 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC)-Formulation |
PRIORITY
|
|
|
| 1977/05/13 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1976/06/10 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1976/04/28 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1975/02/21 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
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:ETHAMBUTOL HYDROCHLORIDE; 剂型/给药途径:TABLET;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 |
|---|
| 016320 |
001 |
NDA |
MYAMBUTOL |
ETHAMBUTOL HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
KANCHAN HLTHCARE |
| 075095 |
001 |
ANDA |
ETHAMBUTOL HYDROCHLORIDE |
ETHAMBUTOL HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1999/11/30
|
EPIC PHARMA LLC |
| 078939 |
001 |
ANDA |
ETHAMBUTOL HYDROCHLORIDE |
ETHAMBUTOL HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2009/06/17
|
LUPIN |
>>>活性成分:ETHAMBUTOL HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:400MG; 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 |
|---|
| 016320 |
003 |
NDA |
MYAMBUTOL |
ETHAMBUTOL HYDROCHLORIDE |
TABLET;ORAL |
400MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
KANCHAN HLTHCARE |
| 075095 |
002 |
ANDA |
ETHAMBUTOL HYDROCHLORIDE |
ETHAMBUTOL HYDROCHLORIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
1999/11/30
|
EPIC PHARMA LLC |
| 076057 |
001 |
ANDA |
ETHAMBUTOL HYDROCHLORIDE |
ETHAMBUTOL HYDROCHLORIDE |
TABLET;ORAL |
400MG |
Discontinued |
No |
No |
AB |
2001/11/26
|
BARR |
| 078939 |
002 |
ANDA |
ETHAMBUTOL HYDROCHLORIDE |
ETHAMBUTOL HYDROCHLORIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2009/06/17
|
LUPIN |
