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 |
|---|
| 1990/04/30 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>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 |
|---|
| 2025/06/13 |
SUPPL-32（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2001/10/16 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 2000/10/06 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 2000/07/07 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 1996/10/11 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 1995/07/07 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/05/11 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/09/27 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/12/29 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/05/01 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1991/06/24 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1990/08/03 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
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:THEOPHYLLINE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:300MG; 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 |
|---|
| 087400 |
002 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
1983/01/11
|
NOSTRUM PHARMS LLC |
| 089763 |
001 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
1990/04/30
|
HERITAGE PHARMA AVET |
| 090430 |
001 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2010/10/27
|
ALEMBIC |
| 212184 |
001 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2021/06/03
|
GLENMARK PHARMS LTD |
| 216961 |
001 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2022/10/12
|
TEVA PHARMS INC |
| 214950 |
001 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2023/01/30
|
VELZEN PHARMA PVT |
| 216276 |
001 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2023/03/20
|
AMNEAL |
| 216300 |
001 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2023/04/26
|
BIONPHARMA |
| 214113 |
001 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Discontinued |
No |
No |
AB |
2023/05/11
|
RHODES PHARMS |
| 217422 |
001 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2023/09/08
|
ANNORA PHARMA |
| 214806 |
001 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2023/10/24
|
HARMAN FINOCHEM |
| 218063 |
001 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2024/05/21
|
ZYDUS LIFESCIENCES |
| 215312 |
001 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2024/09/05
|
STRIDES PHARMA |
| 218401 |
002 |
ANDA |
THEOPHYLLINE |
THEOPHYLLINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Discontinued |
No |
No |
AB |
2025/03/26
|
AJANTA PHARMA LTD |