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 |
2023/07/05 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
2022/01/07 |
ORIG-1(原始申请) |
Approval |
|
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:FAMOTIDINE 剂型/给药途径:TABLET;ORAL 规格:20MG 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 |
075718 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2001/04/16
|
DR REDDYS LABS LTD |
075786 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2001/04/16
|
CHARTWELL RX |
075805 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2001/04/16
|
CARLSBAD |
075302 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2001/04/16
|
MANKIND PHARMA |
075511 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2001/04/16
|
IVAX SUB TEVA PHARMS |
075611 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2001/07/23
|
APOTEX |
077352 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Discontinued |
No |
No |
AB |
2005/07/27
|
PERRIGO R AND D |
078916 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2009/05/22
|
ALEMBIC PHARMS LTD |
206530 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2015/12/22
|
AUROBINDO PHARMA LTD |
215689 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2021/10/15
|
ASCENT PHARMS INC |
215767 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2021/11/04
|
ANNORA PHARMA |
215630 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2022/01/07
|
ALKEM LABS LTD |
216441 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2022/06/03
|
ZYDUS PHARMS |
217375 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/04/24
|
ALKEM LABS LTD |
217669 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/12/20
|
CONTRACT PHARMACAL |
218181 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/12/22
|
GRAVITI PHARMS |
217400 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2024/08/06
|
MSN |
活性成分:FAMOTIDINE 剂型/给药途径:TABLET;ORAL 规格:40MG 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 |
075718 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2001/04/16
|
DR REDDYS LABS LTD |
075786 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2001/04/16
|
CHARTWELL RX |
075805 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2001/04/16
|
CARLSBAD |
075302 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2001/04/16
|
MANKIND PHARMA |
075511 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2001/04/16
|
IVAX SUB TEVA PHARMS |
075611 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2001/07/23
|
APOTEX |
077352 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Discontinued |
No |
No |
AB |
2005/07/27
|
PERRIGO R AND D |
078916 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2009/05/22
|
ALEMBIC PHARMS LTD |
206530 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
Yes |
AB |
2015/12/22
|
AUROBINDO PHARMA LTD |
215689 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2021/10/15
|
ASCENT PHARMS INC |
215767 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2021/11/04
|
ANNORA PHARMA |
215630 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2022/01/07
|
ALKEM LABS LTD |
216441 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2022/06/03
|
ZYDUS PHARMS |
217375 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/04/24
|
ALKEM LABS LTD |
217669 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/12/20
|
CONTRACT PHARMACAL |
218181 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/12/22
|
GRAVITI PHARMS |
217400 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2024/08/06
|
MSN |