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 |
|---|
| 2023/10/23 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/10/23 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/10/23 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/12/23 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 2015/12/23 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2013/01/28 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2008/11/12 |
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:ALPRAZOLAM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:0.5MG 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 |
|---|
| 021434 |
001 |
NDA |
XANAX XR |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
0.5MG |
Prescription |
Yes |
No |
AB |
2003/01/17
|
UPJOHN |
| 078056 |
001 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2007/02/13
|
ACTAVIS ELIZABETH |
| 078387 |
001 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2008/05/30
|
AMNEAL PHARMS NY |
| 078449 |
001 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2008/11/12
|
APOTEX INC |
| 090871 |
001 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2011/06/07
|
AUROBINDO PHARMA |
| 078469 |
001 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
0.5MG |
Discontinued |
No |
No |
AB |
2011/09/29
|
ENDO OPERATIONS |
活性成分:ALPRAZOLAM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:2MG 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 |
|---|
| 021434 |
003 |
NDA |
XANAX XR |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
Yes |
No |
AB |
2003/01/17
|
UPJOHN |
| 078056 |
003 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
No |
No |
AB |
2007/02/13
|
ACTAVIS ELIZABETH |
| 078387 |
003 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
No |
No |
AB |
2008/05/30
|
AMNEAL PHARMS NY |
| 078449 |
002 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
No |
No |
AB |
2008/11/12
|
APOTEX INC |
| 090871 |
003 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
2MG |
Prescription |
No |
No |
AB |
2011/06/07
|
AUROBINDO PHARMA |
| 078469 |
003 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
2MG |
Discontinued |
No |
No |
AB |
2011/09/29
|
ENDO OPERATIONS |
活性成分:ALPRAZOLAM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:3MG 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 |
|---|
| 021434 |
004 |
NDA |
XANAX XR |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
Yes |
Yes |
AB |
2003/01/17
|
UPJOHN |
| 078056 |
004 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2007/02/13
|
ACTAVIS ELIZABETH |
| 078387 |
004 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2008/05/30
|
AMNEAL PHARMS NY |
| 078449 |
003 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2008/11/12
|
APOTEX INC |
| 090871 |
004 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Prescription |
No |
No |
AB |
2011/06/07
|
AUROBINDO PHARMA |
| 078469 |
004 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Discontinued |
No |
No |
AB |
2011/09/29
|
ENDO OPERATIONS |
活性成分:ALPRAZOLAM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:1MG 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 |
|---|
| 021434 |
002 |
NDA |
XANAX XR |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
1MG |
Prescription |
Yes |
No |
AB |
2003/01/17
|
UPJOHN |
| 078056 |
002 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
1MG |
Prescription |
No |
No |
AB |
2007/02/13
|
ACTAVIS ELIZABETH |
| 078387 |
002 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
1MG |
Prescription |
No |
No |
AB |
2008/05/30
|
AMNEAL PHARMS NY |
| 090871 |
002 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
1MG |
Prescription |
No |
No |
AB |
2011/06/07
|
AUROBINDO PHARMA |
| 078469 |
002 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
1MG |
Discontinued |
No |
No |
AB |
2011/09/29
|
ENDO OPERATIONS |
| 078449 |
004 |
ANDA |
ALPRAZOLAM |
ALPRAZOLAM |
TABLET, EXTENDED RELEASE;ORAL |
1MG |
Prescription |
No |
No |
AB |
2015/12/23
|
APOTEX INC |