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 |
|---|
| 2013/05/06 |
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 |
|---|
| 2025/02/11 |
SUPPL-9（补充） |
Approval |
Labeling-Container/Carton Labels,Labeling-Package Insert |
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:ALLOPURINOL; 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 |
|---|
| 016084 |
001 |
NDA |
ZYLOPRIM |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
CASPER PHARMA LLC |
| 018832 |
002 |
NDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1984/09/28
|
WATSON LABS |
| 018659 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1986/10/24
|
MYLAN |
| 071450 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1987/01/09
|
SUN PHARM INDUSTRIES |
| 071586 |
001 |
ANDA |
LOPURIN |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1987/04/02
|
DR REDDYS |
| 075798 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2003/06/27
|
PH HEALTH |
| 077353 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2005/09/08
|
CHARTWELL |
| 078253 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Discontinued |
No |
No |
AB |
2007/09/11
|
NORTHSTAR HLTHCARE |
| 090637 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Discontinued |
No |
No |
AB |
2011/03/16
|
IPCA LABS LTD |
| 203154 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2013/05/06
|
ACCORD HLTHCARE |
| 204467 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2016/07/28
|
REGCON HOLDINGS |
| 210117 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2017/10/12
|
ZYDUS PHARMS |
| 211820 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2019/03/12
|
UNICHEM |
| 214443 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/03/07
|
HARMAN FINOCHEM |
| 217748 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2023/08/03
|
HETERO LABS LTD V |
| 211807 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Discontinued |
No |
No |
AB |
2023/12/14
|
LUPIN LTD |
| 215091 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2025/04/14
|
AUROBINDO PHARMA LTD |
>>>活性成分:ALLOPURINOL; 剂型/给药途径:TABLET;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 |
|---|
| 016084 |
002 |
NDA |
ZYLOPRIM |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
CASPER PHARMA LLC |
| 018877 |
001 |
NDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
1984/09/28
|
WATSON LABS |
| 018659 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
1986/10/24
|
MYLAN |
| 071450 |
001 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
1987/01/09
|
SUN PHARM INDUSTRIES |
| 071587 |
001 |
ANDA |
LOPURIN |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
1987/04/02
|
DR REDDYS |
| 075798 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2003/06/27
|
PH HEALTH |
| 077353 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2005/09/08
|
CHARTWELL |
| 078253 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Discontinued |
No |
No |
AB |
2007/09/11
|
NORTHSTAR HLTHCARE |
| 090637 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Discontinued |
No |
No |
AB |
2011/03/16
|
IPCA LABS LTD |
| 203154 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2013/05/06
|
ACCORD HLTHCARE |
| 204467 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2016/07/28
|
REGCON HOLDINGS |
| 210117 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2017/10/12
|
ZYDUS PHARMS |
| 211820 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
Yes |
AB |
2019/03/12
|
UNICHEM |
| 214443 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2022/03/07
|
HARMAN FINOCHEM |
| 217748 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2023/08/03
|
HETERO LABS LTD V |
| 211807 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Discontinued |
No |
No |
AB |
2023/12/14
|
LUPIN LTD |
| 215091 |
002 |
ANDA |
ALLOPURINOL |
ALLOPURINOL |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2025/04/14
|
AUROBINDO PHARMA LTD |